National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 11) (Cth)
PB 105 of 2023
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023
(No. 11)
National Health Act 1953
I, EDEN SIMON, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 30 October 2023
EDEN SIMON
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Contents
1......... Name............................................................................................................................... 1
2......... Commencement............................................................................................................... 1
3......... Authority......................................................................................................................... 1
4......... Schedules......................................................................................................................... 1
Schedule 1—Amendments 2
National Health (Listing of Pharmaceutical Benefits) Instrument 2012
(PB 71 of 2012). 2
Name
(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 11).
(2)This Instrument may also be cited as PB 105 of 2023.
Commencement
(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement information | ||
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | 1 November 2023 | 1 November 2023 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
Authority
This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
4 Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments
National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1, Part 1, entry for Abatacept
substitute:
| Abatacept | Injection 125 mg in 1 mL single dose autoinjector | Injection | Orencia ClickJect | BQ | MP | C14488 C14507 C14519 C14522 C14560 C14583 C14604 | P14488 P14522 P14560 P14583 | 4 | 3 | 4 |
| MP | C14488 C14507 C14519 C14522 C14560 C14583 C14604 | P14507 P14519 P14604 | 4 | 5 | 4 | |||||
| Injection 125 mg in 1 mL single dose pre-filled syringe | Injection | Orencia | BQ | MP | C14488 C14507 C14519 C14522 C14560 C14583 C14604 | P14488 P14522 P14560 P14583 | 4 | 3 | 4 | |
| MP | C14488 C14507 C14519 C14522 C14560 C14583 C14604 | P14507 P14519 P14604 | 4 | 5 | 4 | |||||
| Powder for I.V. infusion 250 mg | Injection | Orencia | BQ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | PB(100) |
| MP | C14555 C14604 | 3 | 5 | 1 | PB(100) |
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
(h)omit from the column headed “Purposes”: P8638
(i)omit from the column headed “Purposes”: P13550
(j)omit from the column headed “Purposes”: P13648
(k)omit from the column headed “Purposes”: P14058
(l)insert in numerical order in the column headed “Purposes”: P14483 P14486 P14488 P14498
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P8638
(j)omit from the column headed “Purposes”: P13550
(k)omit from the column headed “Purposes”: P13648
(l)omit from the column headed “Purposes”: P14058
(m)insert in numerical order in the column headed “Purposes”: P14483 P14486 P14488 P14496 P14498 P14568 P14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only: Nil]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
(h)omit from the column headed “Purposes”: P11720
(i)omit from the column headed “Purposes”: P11769 P11772
(j)insert in numerical order in the column headed “Purposes”: P14493 P14499 P14507
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only: Nil]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P11605
(j)omit from the column headed “Purposes”: P11720
(k)omit from the column headed “Purposes”: P11769 P11772
(l)insert in numerical order in the column headed “Purposes”: P14493 P14499 P14507 P14567
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira; Maximum Quantity: 4; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 4; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira; Maximum Quantity: 4; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 4; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira; Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
(h)omit from the column headed “Purposes”: P8638
(i)omit from the column headed “Purposes”: P13550
(j)omit from the column headed “Purposes”: P13648
(k)omit from the column headed “Purposes”: P14058
(l)insert in numerical order in the column headed “Purposes”: P14483 P14486 P14488 P14498
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P8638
(j)omit from the column headed “Purposes”: P13550
(k)omit from the column headed “Purposes”: P13648
(l)omit from the column headed “Purposes”: P14058
(m)insert in numerical order in the column headed “Purposes”: P14483 P14486 P14488 P14496 P14498 P14568 P14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only: Nil]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
(h)omit from the column headed “Purposes”: P11720
(i)omit from the column headed “Purposes”: P11769 P11772
(j)insert in numerical order in the column headed “Purposes”: P14493 P14499 P14507
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only: Nil]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P11605
(j)omit from the column headed “Purposes”: P11720
(k)omit from the column headed “Purposes”: P11769 P11772
(l)insert in numerical order in the column headed “Purposes”: P14493 P14499 P14507 P14567
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Humira; Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11720
(c)omit from the column headed “Circumstances”: C11769 C11772
(d)omit from the column headed “Circumstances”: C13550
(e)omit from the column headed “Circumstances”: C13648
(f)omit from the column headed “Circumstances”: C14058
(g)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14498 C14499 C14507
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Yuflyma; Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P8638
(j)omit from the column headed “Purposes”: P13550
(k)omit from the column headed “Purposes”: P13648
(l)omit from the column headed “Purposes”: P14058
(m)insert in numerical order in the column headed “Purposes”: P14483 P14486 P14488 P14496 P14498 P14568 P14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P8638
(j)omit from the column headed “Purposes”: P13550
(k)omit from the column headed “Purposes”: P13648
(l)omit from the column headed “Purposes”: P14058
(m)insert in numerical order in the column headed “Purposes”: P14483 P14486 P14488 P14496 P14498 P14568 P14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P8638
(j)omit from the column headed “Purposes”: P13550
(k)omit from the column headed “Purposes”: P13648
(l)omit from the column headed “Purposes”: P14058
(m)insert in numerical order in the column headed “Purposes”: P14483 P14486 P14488 P14496 P14498 P14568 P14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P8638
(j)omit from the column headed “Purposes”: P13550
(k)omit from the column headed “Purposes”: P13648
(l)omit from the column headed “Purposes”: P14058
(m)insert in numerical order in the column headed “Purposes”: P14483 P14486 P14488 P14496 P14498 P14568 P14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only: Nil]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P11605
(j)omit from the column headed “Purposes”: P11720
(k)omit from the column headed “Purposes”: P11769 P11772
(l)insert in numerical order in the column headed “Purposes”: P14493 P14499 P14507 P14567
(m)
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only: Nil]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P11605
(j)omit from the column headed “Purposes”: P11720
(k)omit from the column headed “Purposes”: P11769 P11772
(l)insert in numerical order in the column headed “Purposes”: P14493 P14499 P14507 P14567
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only: Nil]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P11605
(j)omit from the column headed “Purposes”: P11720
(k)omit from the column headed “Purposes”: P11769 P11772
(l)insert in numerical order in the column headed “Purposes”: P14493 P14499 P14507 P14567
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only: Nil]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P11605
(j)omit from the column headed “Purposes”: P11720
(k)omit from the column headed “Purposes”: P11769 P11772
(l)insert in numerical order in the column headed “Purposes”: P14493 P14499 P14507 P14567
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 4; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 4; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 4; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 4; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 4; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 4; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 4; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 4; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Idacio; Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P8638
(j)omit from the column headed “Purposes”: P13550
(k)omit from the column headed “Purposes”: P13648
(l)omit from the column headed “Purposes”: P14058
(m)insert in numerical order in the column headed “Purposes”: P14483 P14486 P14488 P14496 P14498 P14568 P14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P8638
(j)omit from the column headed “Purposes”: P13550
(k)omit from the column headed “Purposes”: P13648
(l)omit from the column headed “Purposes”: P14058
(m)insert in numerical order in the column headed “Purposes”: P14483 P14486 P14488 P14496 P14498 P14568 P14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P8638
(j)omit from the column headed “Purposes”: P13550
(k)omit from the column headed “Purposes”: P13648
(l)omit from the column headed “Purposes”: P14058
(m)insert in numerical order in the column headed “Purposes”: P14483 P14486 P14488 P14496 P14498 P14568 P14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P8638
(j)omit from the column headed “Purposes”: P13550
(k)omit from the column headed “Purposes”: P13648
(l)omit from the column headed “Purposes”: P14058
(m)insert in numerical order in the column headed “Purposes”: P14483 P14486 P14488 P14496 P14498 P14568 P14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only: Nil]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P11605
(j)omit from the column headed “Purposes”: P11720
(k)omit from the column headed “Purposes”: P11769 P11772
(l)insert in numerical order in the column headed “Purposes”: P14493 P14499 P14507 P14567
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only: Nil]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P11605
(j)omit from the column headed “Purposes”: P11720
(k)omit from the column headed “Purposes”: P11769 P11772
(l)insert in numerical order in the column headed “Purposes”: P14493 P14499 P14507 P14567
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only: Nil]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P11605
(j)omit from the column headed “Purposes”: P11720
(k)omit from the column headed “Purposes”: P11769 P11772
(l)insert in numerical order in the column headed “Purposes”: P14493 P14499 P14507 P14567
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Idacio; Maximum Quantity: 2; Number of Repeats: 5; Section 100/ Prescriber Bag only: Nil]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)omit from the column headed “Purposes”: P11605
(j)omit from the column headed “Purposes”: P11720
(k)omit from the column headed “Purposes”: P11769 P11772
(l)insert in numerical order in the column headed “Purposes”: P14493 P14499 P14507 P14567
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
(i)
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Idacio; Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8638
(b)omit from the column headed “Circumstances”: C11605
(c)omit from the column headed “Circumstances”: C11720
(d)omit from the column headed “Circumstances”: C11769 C11772
(e)omit from the column headed “Circumstances”: C13550
(f)omit from the column headed “Circumstances”: C13648
(g)omit from the column headed “Circumstances”: C14058
(h)insert in numerical order in the column headed “Circumstances”: C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590
Schedule 1, Part 1, entry for Amlodipine with valsartan
substitute:
| Amlodipine with valsartan | Tablet 5 mg (as besilate)-80 mg | Oral | a | Amlodipine/Valsartan Novartis 5/80 | NM | MP NP | C4373 C14257 | P4373 | 28 | 5 | 28 |
| a | Exforge 5/80 | NV | MP NP | C4373 C14257 | P4373 | 28 | 5 | 28 | |||
| a | Amlodipine/Valsartan Novartis 5/80 | NM | MP NP | C4373 C14257 | P14257 | 56 | 5 | 28 | |||
| a | Exforge 5/80 | NV | MP NP | C4373 C14257 | P14257 | 56 | 5 | 28 | |||
| Tablet 5 mg (as besilate)-160 mg | Oral | a | Amlodipine/Valsartan Novartis 5/160 | NM | MP NP | C4373 C14257 | P4373 | 28 | 5 | 28 | |
| a | Exforge 5/160 | NV | MP NP | C4373 C14257 | P4373 | 28 | 5 | 28 | |||
| a | Amlodipine/Valsartan Novartis 5/160 | NM | MP NP | C4373 C14257 | P14257 | 56 | 5 | 28 | |||
| a | Exforge 5/160 | NV | MP NP | C4373 C14257 | P14257 | 56 | 5 | 28 | |||
| Tablet 5 mg (as besilate)-320 mg | Oral | a | Amlodipine/Valsartan Novartis 5/320 | NM | MP NP | C4373 C14257 | P4373 | 28 | 5 | 28 | |
| a | Exforge 5/320 | NV | MP NP | C4373 C14257 | P4373 | 28 | 5 | 28 | |||
| a | Amlodipine/Valsartan Novartis 5/320 | NM | MP NP | C4373 C14257 | P14257 | 56 | 5 | 28 | |||
| a | Exforge 5/320 | NV | MP NP | C4373 C14257 | P14257 | 56 | 5 | 28 | |||
| Tablet 10 mg (as besilate)-160 mg | Oral | a | Amlodipine/Valsartan Novartis 10/160 | NM | MP NP | C4373 C14257 | P4373 | 28 | 5 | 28 | |
| a | Exforge 10/160 | NV | MP NP | C4373 C14257 | P4373 | 28 | 5 | 28 | |||
| a | Amlodipine/Valsartan Novartis 10/160 | NM | MP NP | C4373 C14257 | P14257 | 56 | 5 | 28 | |||
| a | Exforge 10/160 | NV | MP NP | C4373 C14257 | P14257 | 56 | 5 | 28 | |||
| Tablet 10 mg (as besilate)-320 mg | Oral | a | Amlodipine/Valsartan Novartis 10/320 | NM | MP NP | C4373 C14257 | P4373 | 28 | 5 | 28 | |
| a | Exforge 10/320 | NV | MP NP | C4373 C14257 | P4373 | 28 | 5 | 28 | |||
| a | Amlodipine/Valsartan Novartis 10/320 | NM | MP NP | C4373 C14257 | P14257 | 56 | 5 | 28 | |||
| a | Exforge 10/320 | NV | MP NP | C4373 C14257 | P14257 | 56 | 5 | 28 |
Schedule 1, Part 1, entry for Amlodipine with valsartan and hydrochlorothiazide
substitute:
| Amlodipine with valsartan and hydrochlorothiazide | Tablet 5 mg (as besilate)-160 mg-12.5 mg | Oral | a | Amlodipine/Valsartan/HCT Novartis 5/160/12.5 | NM | MP NP | C4311 C14272 | P4311 | 28 | 5 | 28 |
| a | Exforge HCT 5/160/12.5 | NV | MP NP | C4311 C14272 | P4311 | 28 | 5 | 28 | |||
| a | Amlodipine/Valsartan/HCT Novartis 5/160/12.5 | NM | MP NP | C4311 C14272 | P14272 | 56 | 5 | 28 | |||
| a | Exforge HCT 5/160/12.5 | NV | MP NP | C4311 C14272 | P14272 | 56 | 5 | 28 | |||
| Tablet 5 mg (as besilate)-160 mg-25 mg | Oral | a | Amlodipine/Valsartan/HCT Novartis 5/160/25 | NM | MP NP | C4311 C14272 | P4311 | 28 | 5 | 28 | |
| a | Exforge HCT 5/160/25 | NV | MP NP | C4311 C14272 | P4311 | 28 | 5 | 28 | |||
| a | Amlodipine/Valsartan/HCT Novartis 5/160/25 | NM | MP NP | C4311 C14272 | P14272 | 56 | 5 | 28 | |||
| a | Exforge HCT 5/160/25 | NV | MP NP | C4311 C14272 | P14272 | 56 | 5 | 28 | |||
| Tablet 10 mg (as besilate)-160 mg-12.5 mg | Oral | a | Amlodipine/Valsartan/HCT Novartis 10/160/12.5 | NM | MP NP | C4311 C14272 | P4311 | 28 | 5 | 28 | |
| a | Exforge HCT 10/160/12.5 | NV | MP NP | C4311 C14272 | P4311 | 28 | 5 | 28 | |||
| a | Amlodipine/Valsartan/HCT Novartis 10/160/12.5 | NM | MP NP | C4311 C14272 | P14272 | 56 | 5 | 28 | |||
| a | Exforge HCT 10/160/12.5 | NV | MP NP | C4311 C14272 | P14272 | 56 | 5 | 28 | |||
| Tablet 10 mg (as besilate)-160 mg-25 mg | Oral | a | Amlodipine/Valsartan/HCT Novartis 10/160/25 | NM | MP NP | C4311 C14272 | P4311 | 28 | 5 | 28 | |
| a | Exforge HCT 10/160/25 | NV | MP NP | C4311 C14272 | P4311 | 28 | 5 | 28 | |||
| a | Amlodipine/Valsartan/HCT Novartis 10/160/25 | NM | MP NP | C4311 C14272 | P14272 | 56 | 5 | 28 | |||
| a | Exforge HCT 10/160/25 | NV | MP NP | C4311 C14272 | P14272 | 56 | 5 | 28 | |||
| Tablet 10 mg (as besilate)-320 mg-25 mg | Oral | a | Amlodipine/Valsartan/HCT Novartis 10/320/25 | NM | MP NP | C4311 C14272 | P4311 | 28 | 5 | 28 | |
| a | Exforge HCT 10/320/25 | NV | MP NP | C4311 C14272 | P4311 | 28 | 5 | 28 | |||
| a | Amlodipine/Valsartan/HCT Novartis 10/320/25 | NM | MP NP | C4311 C14272 | P14272 | 56 | 5 | 28 | |||
| a | Exforge HCT 10/320/25 | NV | MP NP | C4311 C14272 | P14272 | 56 | 5 | 28 |
Schedule 1, Part 1, after entry for Amoxicillin with clavulanic acid in the form Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL
insert:
| Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 50 mL (S19A) | Oral | Amoxicillin and clavulanate potassium for oral suspension, USP 400 mg/57 mg per 5 mL (Aurobindo) | DZ | PDP | C5833 C5894 | 1 | 0 | 1 |
| MP NP | C5832 C5893 | 1 | 1 | 1 |
Schedule 4, Part 1, entry for Ustekinumab
(a)omit:
| C12294 | P12294 | Severe chronic plaque psoriasis Initial 2 treatment (Face, hand, foot) - Change or recommencement of treatment after a break in biological medicine of less than 5 years Must be treated by a dermatologist. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Response to preceding supply: An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. Change in therapy: If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because: (i) there is an absence of an adequate response to that treatment; or (ii) there was an intolerance to that treatment; or (iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above Recommencing therapy: If the patient is recommencing therapy, in relation to the last administered dose, state whether there was: (i) an absence of an adequate response; or (ii) an intolerance to that treatment; or (iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above. | Compliance with Written Authority Required procedures |
| C12302 | P12302 | Severe chronic plaque psoriasis Continuing treatment (Face, hand, foot) - treatment covering week 28 and onwards Must be treated by a dermatologist. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. | Compliance with Written Authority Required procedures |
| C12311 | P12311 | Severe chronic plaque psoriasis Continuing treatment (Whole body) - treatment covering week 28 and onwards Must be treated by a dermatologist. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment. | Compliance with Written Authority Required procedures |
| C12323 | P12323 | Severe chronic plaque psoriasis Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years Must be treated by a dermatologist. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words 'whole body'; OR The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words 'face, hand, foot'; AND Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; OR The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C12332 | P12332 | Severe chronic plaque psoriasis Initial 2 treatment (Whole body) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years Must be treated by a dermatologist. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Response to preceding supply: An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. Change in therapy: If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because: (i) there is an absence of an adequate response to that treatment; or (ii) there was an intolerance to that treatment; or (iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above Recommencing therapy: If the patient is recommencing therapy, in relation to the last administered dose, state whether there was: (i) an absence of an adequate response; or (ii) an intolerance to that treatment; or (iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above. | Compliance with Written Authority Required procedures |
| C12333 | P12333 | Severe chronic plaque psoriasis Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient Must be treated by a dermatologist. Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy: (a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or (b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy State in this authority application, each of: (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled; (iv) the dates that response assessments were determined State in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment: (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe); (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine. | Compliance with Written Authority Required procedures |
(b)omit:
| C12341 | P12341 | Severe chronic plaque psoriasis Initial 1 treatment (Whole body) - biological medicine-naive patient Must be treated by a dermatologist. Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy: (a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy. A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. State in this authority application, each of: (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) the PASI score that followed each prior therapy trialled; (iv) the date the PASI scores were determined State a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine. | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text:
| C14543 | P14543 | Severe chronic plaque psoriasis Initial 1 treatment (Whole body) - biological medicine-naive patient Must be treated by a dermatologist. Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy: (a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy. A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. Provide in this authority application, and document in the patient's medical records, each of: (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) the PASI score that followed each prior therapy trialled; (iv) the date the PASI scores were determined. Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine. | Compliance with Written Authority Required procedures |
| C14558 | P14558 | Severe chronic plaque psoriasis Continuing treatment (Whole body) - treatment covering week 28 and onwards Must be treated by a dermatologist. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. The assessment of response to treatment must be provided in this application and documented in the patient's medical records. The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment. | Compliance with Written Authority Required procedures |
| C14572 | P14572 | Severe chronic plaque psoriasis Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years Must be treated by a dermatologist. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words 'whole body'; OR The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words 'face, hand, foot'; AND Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; OR The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. The most recent PASI assessment must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C14573 | P14573 | Severe chronic plaque psoriasis Initial 2 treatment (Face, hand, foot) - Change or recommencement of treatment after a break in biological medicine of less than 5 years Must be treated by a dermatologist. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application. Response to preceding supply: An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. Change in therapy: If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because: (i) there is an absence of an adequate response to that treatment; or (ii) there was an intolerance to that treatment; or (iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above Recommencing therapy: If the patient is recommencing therapy, in relation to the last administered dose, state whether there was: (i) an absence of an adequate response; or (ii) an intolerance to that treatment; or (iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above. The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient's medical records. | Compliance with Written Authority Required procedures |
| C14628 | P14628 | Severe chronic plaque psoriasis Continuing treatment (Face, hand, foot) - treatment covering week 28 and onwards Must be treated by a dermatologist. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. The assessment of response to treatment must be provided in this application and documented in the patient's medical records. | Compliance with Written Authority Required procedures |
| C14636 | P14636 | Severe chronic plaque psoriasis Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient Must be treated by a dermatologist. Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy: (a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or (b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy Provide in this authority application, and document in the patient's medical records, each of: (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled; (iv) the dates that response assessments were determined. Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment: (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe); (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine. | Compliance with Written Authority Required procedures |
| C14643 | P14643 | Severe chronic plaque psoriasis Initial 2 treatment (Whole body) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years Must be treated by a dermatologist. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application. Response to preceding supply: An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. Change in therapy: If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because: (i) there is an absence of an adequate response to that treatment; or (ii) there was an intolerance to that treatment; or (iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above Recommencing therapy: If the patient is recommencing therapy, in relation to the last administered dose, state whether there was: (i) an absence of an adequate response; or (ii) an intolerance to that treatment; or (iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above. The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient's medical records. | Compliance with Written Authority Required procedures |
Schedule 5, after entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A)
insert:
| GRP-28006 | Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 50 mL (S19A) | Oral | Amoxicillin and clavulanate potassium for oral suspension, USP 400 mg/57 mg per 5 mL (Aurobindo) |
| Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL | Oral | Augmentin Duo 400 Curam Duo |
Schedule 5, after entry for Methylprednisolone in the form Powder for injection 40 mg (as sodium succinate) with diluent
insert:
| Powder for injection 40 mg (as sodium succinate) (S19A) | Injection | Solu-Medrone |
Schedule 5, entry for Varenicline in the form Tablet 1 mg (as tartrate)
insert in alphabetical order in the column headed “Brand”: PHARMACOR VARENICLINE
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