National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 9) (PB 76 of 2019) (Cth)
PB 76 of 2019
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 9)
National Health Act 1953
________________________________________________________________________
I, THEA DANIEL, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 30th September 2019
THEA DANIEL
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health
Name of Instrument
(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 9).
(2)This Instrument may also be cited as PB 76 of 2019.
Commencement
This Instrument commences on 1 October 2019.
Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
Section 11 Authority required procedures
omit:
(3)In all circumstances mentioned in Part 1 of Schedule 4 for a circumstances code mentioned in Schedule 1 for the pharmaceutical benefit, except those which include a Streamlined Authority Code, a medication chart prescription for a person receiving treatment in a residential care service may not be authorised under the authority required procedures in sections 11 to 15.
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531
(b)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(c)insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531
(b)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(c)insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531
(b)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(c)insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631
(d)omit from the column headed “Purposes”: P4492 P4501 P4518 P8059 P8060 P8073
(e)insert in numerical order in the column headed “Purposes”: P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531
(b)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(c)insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531
(b)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(c)insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631
(d)omit from the column headed “Purposes”: P4517 P4531
(e)omit from the column headed “Purposes”: P8041 P8074
(f)insert in numerical order in the column headed “Purposes”: P9380 P9430 P9431 P9631
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531
(b)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(c)insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531
(b)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(c)insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531
(b)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(c)insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631
(d)omit from the column headed “Purposes”: P4492 P4501 P4518 P8059 P8060 P8073
(e)insert in numerical order in the column headed “Purposes”: P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531
(b)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(c)insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4492 C4501 C4517 C4518 C4531
(b)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(c)insert in numerical order in the column headed “Circumstances”: C9380 C9386 C9409 C9414 C9428 C9429 C9430 C9431 C9498 C9503 C9564 C9631
(d)omit from the column headed “Purposes”: P4517 P4531
(e)omit from the column headed “Purposes”: P8041 P8074
(f)insert in numerical order in the column headed “Purposes”: P9380 P9430 P9431 P9631
Schedule 1, entry for Alemtuzumab in the form Solution concentrate for I.V. infusion 12 mg in 1.2 mL [Maximum Quantity: 3;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C6878
(b)omit from the column headed “Circumstances”: C7743
(c)insert in numerical order in the column headed “Circumstances”: C9589 C9636
(d)omit from the column headed “Purposes”: P6878
(e)insert in numerical order in the column headed “Purposes”: P9589
Schedule 1, entry for Alemtuzumab in the form Solution concentrate for I.V. infusion 12 mg in 1.2 mL [Maximum Quantity: 5;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C6878
(b)omit from the column headed “Circumstances”: C7743
(c)insert in numerical order in the column headed “Circumstances”: C9589 C9636
(d)omit from the column headed “Purposes”: P7743
(e)insert in numerical order in the column headed “Purposes”: P9636
Schedule 1, entry for Amoxicillin in the form Capsule 250 mg (as trihydrate)
omit from the column headed “Responsible Person” for the brand “Cilamox” (twice occurring): QA substitute: AL
Schedule 1, entry for Amoxicillin in the form Capsule 500 mg (as trihydrate)
omit from the column headed “Responsible Person” for the brand “Cilamox” (twice occurring): QA substitute: AL
Schedule 1, entry for Apomorphine in each of the forms: Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL; and Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL
(a)omit from the column headed "Circumstances": C4860
(b)insert in numerical order in the column headed “Circumstances”: C9561
Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20
(a)omit from the column headed "Circumstances": C4860
(b)insert in numerical order in the column headed “Circumstances”: C9561
Schedule 1, entry for Apomorphine in the form Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen
(a)omit from the column headed "Circumstances" (twice occurring): C4860
(b)insert in numerical order in the column headed “Circumstances” (twice occurring): C9561
Schedule 1, entry for Apomorphine in the form Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe
(a)omit from the column headed "Circumstances": C4860
(b)insert in numerical order in the column headed “Circumstances”: C9561
Schedule 1, after entry for Apraclonidine in the form Eye drops 5 mg (as hydrochloride) per mL, 10 mL
insert:
| Aprepitant | Capsule 165 mg | Oral | Aprepitant APOTEX | TX | MP NP | C4211 C4215 C6370 C6444 | 1 | 5 | 1 |
| MP | C4216 C4223 C6383 C6464 | 1 | 5 | 1 | C(100) |
Schedule 1, entry for Aripiprazole in each of the forms: Tablet 10 mg; Tablet 15 mg; Tablet 20 mg; and Tablet 30 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Aripiprazole generichealth | HQ | MP NP | C4246 | 30 | 5 | 30 |
Schedule 1, entry for Atezolizumab
insert in numerical order in the column headed “Circumstances”: C9345 C9348 C9514 C9567
Schedule 1, entry for Aurothiomalate
omit:
| Injection containing sodium aurothiomalate 50 mg | Injection | Myocrisin | SW | MP NP | 10 | 1 | 10 |
Schedule 1, entry for Azithromycin in the form Tablet 600 mg (as dihydrate)
(a)omit from the column headed “Circumstances”: C6361
(b)insert in numerical order in the column headed “Circumstances”: C9604
Schedule 1, entry for Baclofen in the form Intrathecal injection 10 mg in 5 mL
(a)omit from the column headed “Circumstances” for the brand “Bacthecal” (twice occurring): C6912
(b)omit from the column headed “Circumstances” for the brand “Bacthecal” (twice occurring): C6929 C6930 C6935
(c)insert in numerical order in the column headed “Circumstances” for the brand “Bacthecal” (twice occurring): C9488 C9489 C9524 C9637
(d)omit from the column headed “Circumstances” for the brand “Lioresal Intrathecal”: C6912
(e)omit from the column headed “Circumstances” for the brand “Lioresal Intrathecal”: C6929 C6930 C6935
(f)insert in numerical order in the column headed “Circumstances” for the brand “Lioresal Intrathecal”: C9488 C9489 C9524 C9637
(g)omit from the column headed “Circumstances” for the brand “Sintetica Baclofen Intrathecal”: C6912
(h)omit from the column headed “Circumstances” for the brand “Sintetica Baclofen Intrathecal”: C6929 C6930 C6935
(i)insert in numerical order in the column headed “Circumstances” for the brand “Sintetica Baclofen Intrathecal”: C9488 C9489 C9524 C9637
Schedule 1, entry for Baclofen in the form Intrathecal injection 40 mg in 20 mL
(a)omit from the column headed “Circumstances”: C7156 C7157 C7159 C7162
(b)insert in numerical order in the column headed “Circumstances”: C9525 C9562 C9606 C9638
Schedule 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg in
16 mL
insert in numerical order in the column headed “Circumstances”: C9346 C9347 C9454 C9566
Schedule 1, omit entry for Biperiden
Schedule 1, entry for Blinatumomab
omit from the column headed “Circumstances”: C8812 C8924 C8949 C8966 substitute: C9369 C9373 C9519 C9551
Schedule 1, entry for Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
(a)omit from the column headed “Responsible Person” for the brand “Aclor 125” (twice occurring): QA substitute: MQ
(b)omit from the column headed “Responsible Person” for the brand “Ceclor” (twice occurring): AS substitute: AL
Schedule 1, entry for Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
(a)omit from the column headed “Responsible Person” for the brand “Aclor 250” (twice occurring): QA substitute: MQ
(b)omit from the column headed “Responsible Person” for the brand “Ceclor” (twice occurring): AS substitute: AL
Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate)
(a)omit from the column headed “Responsible Person” for the brand “Ceclor CD” (twice occurring): AS substitute: AL
(b)omit from the column headed “Responsible Person” for the brand “Karlor CD” (twice occurring): LN substitute: MQ
Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g (as hydrochloride)
omit:
| a | DBL Cefepime | PF | MP NP | C5842 | 10 | 0 | 1 |
Schedule 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8041 C8074 C8076 C8097 C8113
(b)insert in numerical order in the column headed “Circumstances”: C9430 C9431 C9442 C9537 C9610 C9625
(c)omit from the column headed “Purposes”: P8113
(d)insert in numerical order in the column headed “Purposes”: P9625
Schedule 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8041 C8074 C8076 C8097 C8113
(b)insert in numerical order in the column headed “Circumstances”: C9430 C9431 C9442 C9537 C9610 C9625
(c)omit from the column headed “Purposes”: P8041 P8074
(d)insert in numerical order in the column headed “Purposes”: P9430 P9431
Schedule 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8041 C8074 C8076 C8097 C8113
(b)insert in numerical order in the column headed “Circumstances”: C9430 C9431 C9442 C9537 C9610 C9625
(c)omit from the column headed “Purposes”: P8076 P8097
(d)insert in numerical order in the column headed “Purposes”: P9442 P9537 P9610
Schedule 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8041 C8074 C8076 C8097 C8113
(b)insert in numerical order in the column headed “Circumstances”: C9430 C9431 C9442 C9537 C9610 C9625
(c)omit from the column headed “Purposes”: P8113
(d)insert in numerical order in the column headed “Purposes”: P9625
Schedule 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8041 C8074 C8076 C8097 C8113
(b)insert in numerical order in the column headed “Circumstances”: C9430 C9431 C9442 C9537 C9610 C9625
(c)omit from the column headed “Purposes”: P8041 P8074
(d)insert in numerical order in the column headed “Purposes”: P9430 P9431
Schedule 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8041 C8074 C8076 C8097 C8113
(b)insert in numerical order in the column headed “Circumstances”: C9430 C9431 C9442 C9537 C9610 C9625
(c)omit from the column headed “Purposes”: P8076 P8097
(d)insert in numerical order in the column headed “Purposes”: P9442 P9537 P9610
Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Clopidogrel Sandoz Pharma | HX | MP NP | C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525 | 28 | 5 | 28 |
Schedule 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex in each of the forms: Lyophilised powder for I.M. injection 300 units; and Lyophilised powder for I.M. injection 500 units
(a)omit from the column headed “Circumstances”: C5220
(b)insert in numerical order in the column headed “Circumstances”: C9463 C9547
Schedule 1, entry for Clozapine in the form Oral liquid 50 mg per mL, 100 mL
(a)omit from the column headed "Circumstances" (twice occurring): C5001
(b)insert in numerical order in the column headed “Circumstances” (twice occurring): C9490
Schedule 1, entry for Clozapine in the form Tablet 25 mg
(a)omit from the column headed "Circumstances" (twice occurring): C5001
(b)insert in numerical order in the column headed “Circumstances” (twice occurring): C9490
Schedule 1, entry for Clozapine in the form Tablet 50 mg
(a)omit from the column headed "Circumstances": C5001
(b)insert in numerical order in the column headed “Circumstances”: C9490
Schedule 1, entry for Clozapine in the form Tablet 100 mg
(a)omit from the column headed "Circumstances" (twice occurring): C5001
(b)insert in numerical order in the column headed “Circumstances” (twice occurring): C9490
Schedule 1, entry for Clozapine in the form Tablet 200 mg
(a)omit from the column headed "Circumstances": C5001
(b)insert in numerical order in the column headed “Circumstances”: C9490
Schedule 1, entry for Codeine with paracetamol
omit from the column headed "Responsible Person" for the brand “Codalgin Forte” (twice occurring): FM substitute: AF
Schedule 1, entry for Colestyramine
omit from the column headed “Responsible Person”: QA substitute: GO
Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136
(b)insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549
(c)omit from the column headed “Purposes”: P9059 P9098 P9100 P9136 substitute: P9367 P9468 P9469 P9549
Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136
(b)insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549
Schedule 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136
(b)insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549
(c)omit from the column headed “Purposes”: P9059 P9098 P9100 P9136 substitute: P9367 P9468 P9469 P9549
Schedule 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136
(b)insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549
Schedule 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136
(b)insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549
(c)omit from the column headed “Purposes”: P9059 P9098 P9100 P9136 substitute: P9367 P9468 P9469 P9549
Schedule 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136
(b)insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549
Schedule 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136
(b)insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549
(c)omit from the column headed “Purposes”: P9059 P9098 P9100 P9136 substitute: P9367 P9468 P9469 P9549
Schedule 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9059 C9098 C9100 C9136
(b)insert in numerical order in the column headed “Circumstances”: C9367 C9468 C9469 C9549
Schedule 1, entry for Deferiprone in the form Tablet 1000 mg
(a)omit from the column headed “Circumstances”: C6380
(b)omit from the column headed “Circumstances”: C6442
(c)insert in numerical order in the column headed “Circumstances”: C9590 C9623
Schedule 1, entry for Dornase alfa
(a)omit from the column headed “Circumstances”: C5715
(b)omit from the column headed “Circumstances”: C5768 C5800
(c)insert in numerical order in the column headed “Circumstances”: C9591 C9592 C9624
Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C4457 C4458 C4482 C4483 C4503
(b)omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8093 C8095 C8103
(c)insert in numerical order in the column headed “Circumstances”: C9375 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554
(d)omit from the column headed “Purposes”: P4458 P4483 P4503
(e)omit from the column headed “Purposes”: P8039 P8040 P8093
(f)insert in numerical order in the column headed “Purposes”: P9375 P9386 P9388 P9410 P9428 P9429 P9473 P9501
Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4457 C4458 C4482 C4483 C4503
(b)omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8093 C8095 C8103
(c)insert in numerical order in the column headed “Circumstances”: C9375 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554
(d)omit from the column headed “Purposes”: P4457 P4482
(e)omit from the column headed “Purposes”: P8054 P8079 P8095 P8103
(f)insert in numerical order in the column headed “Purposes”: P9377 P9380 P9487 P9502 P9554
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8092 C8093 C8095 C8103
(b)insert in numerical order in the column headed “Circumstances”: C9410 C9428 C9429 C9481 C9487 C9501 C9502 C9554
(c)omit from the column headed “Purposes”: P8039 P8040 P8093
(d)insert in numerical order in the column headed “Purposes”: P9410 P9428 P9429 P9501
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C4457 C4458 C4482 C4483 C4503
(b)omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8093 C8095 C8103
(c)insert in numerical order in the column headed “Circumstances”: C9375 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554
(d)omit from the column headed “Purposes”: P4458 P4483 P4503
(e)omit from the column headed “Purposes”: P8039 P8040 P8093
(f)insert in numerical order in the column headed “Purposes”: P9375 P9386 P9388 P9410 P9428 P9429 P9473 P9501
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8092 C8093 C8095 C8103
(b)insert in numerical order in the column headed “Circumstances”: C9410 C9428 C9429 C9481 C9487 C9501 C9502 C9554
(c)omit from the column headed “Purposes”: P8054 P8079 P8092 P8095 P8103
(d)insert in numerical order in the column headed “Purposes”: P9481 P9487 P9502 P9554
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4457 C4458 C4482 C4483 C4503
(b)omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8093 C8095 C8103
(c)insert in numerical order in the column headed “Circumstances”: C9375 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554
(d)omit from the column headed “Purposes”: P4457 P4482
(e)omit from the column headed “Purposes”: P8054 P8079 P8095 P8103
(f)insert in numerical order in the column headed “Purposes”: P9377 P9380 P9487 P9502 P9554
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8092 C8093 C8095 C8103
(b)insert in numerical order in the column headed “Circumstances”: C9410 C9428 C9429 C9481 C9487 C9501 C9502 C9554
(c)omit from the column headed “Purposes”: P8039 P8040 P8093
(d)insert in numerical order in the column headed “Purposes”: P9410 P9428 P9429 P9501
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C4457 C4458 C4482 C4483 C4503
(b)omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8093 C8095 C8103
(c)insert in numerical order in the column headed “Circumstances”: C9375 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554
(d)omit from the column headed “Purposes”: P4458 P4483 P4503
(e)omit from the column headed “Purposes”: P8039 P8040 P8093
(f)insert in numerical order in the column headed “Purposes”: P9375 P9386 P9388 P9410 P9428 P9429 P9473 P9501
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8092 C8093 C8095 C8103
(b)insert in numerical order in the column headed “Circumstances”: C9410 C9428 C9429 C9481 C9487 C9501 C9502 C9554
(c)omit from the column headed “Purposes”: P8054 P8079 P8092 P8095 P8103
(d)insert in numerical order in the column headed “Purposes”: P9481 P9487 P9502 P9554
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4457 C4458 C4482 C4483 C4503
(b)omit from the column headed “Circumstances”: C8039 C8040 C8054 C8079 C8093 C8095 C8103
(c)insert in numerical order in the column headed “Circumstances”: C9375 C9377 C9380 C9386 C9388 C9410 C9428 C9429 C9473 C9487 C9501 C9502 C9554
(d)omit from the column headed “Purposes”: P4457 P4482
(e)omit from the column headed “Purposes”: P8054 P8079 P8095 P8103
(f)insert in numerical order in the column headed “Purposes”: P9377 P9380 P9487 P9502 P9554
Schedule 1, entry for Filgrastim
substitute:
| Filgrastim | Injection 120 micrograms in 0.2 mL single-use pre-filled syringe | Injection | Nivestim | PF | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | 10 | D(100) |
| Injection 300 micrograms in 0.5 mL single-use pre-filled syringe | Injection | Zarzio | SZ | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | 5 | D(100) | |
| Neupogen | AN | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | 10 | D(100) | |||
| Nivestim | PF | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | 10 | D(100) | |||
| Injection 300 micrograms in 1 mL | Injection | Neupogen | AN | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | 10 | D(100) | |
| Injection 480 micrograms in 0.5 mL single-use pre-filled syringe | Injection | Zarzio | SZ | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | 5 | D(100) | |
| Neupogen | AN | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | 10 | D(100) | |||
| Nivestim | PF | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | 10 | D(100) | |||
| Injection 480 micrograms in 1.6 mL | Injection | Neupogen | AN | MP | C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696 | 20 | 11 | 10 | D(100) |
Schedule 1, entry for Flucloxacillin in the form Capsule 250 mg (as sodium monohydrate)
omit from the column headed “Responsible Person”: AS substitute: AL
Schedule 1, entry for Flucloxacillin in the form Capsule 500 mg (as sodium monohydrate)
omit from the column headed “Responsible Person”: AS substitute: AL
Schedule 1, omit entry for Fluticasone
Schedule 1, after entry for Fluticasone furoate with vilanterol in the form Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses
insert:
| Fluticasone propionate | Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation) | Inhalation by mouth | Flixotide Junior | GK | MP NP | 1 | 5 | 1 |
| Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation) | Inhalation by mouth | a | Flixotide | GK | MP NP | 1 | 5 | 1 |
| a | Fluticasone Cipla Inhaler | LR | MP NP | 1 | 5 | 1 | ||
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses | Inhalation by mouth | Flixotide Junior Accuhaler | GK | MP NP | 1 | 5 | 1 | |
| Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC-free formulation) | Inhalation by mouth | a | Flixotide | GK | MP NP | 1 | 1 | 1 |
| a | Fluticasone Cipla Inhaler | LR | MP NP | 1 | 1 | 1 | ||
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses | Inhalation by mouth | Flixotide Accuhaler | GK | MP NP | 1 | 5 | 1 | |
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms per dose, 60 doses | Inhalation by mouth | Flixotide Accuhaler | GK | MP NP | 1 | 1 | 1 |
Schedule 1, entry for Fluticasone with formoterol
omit from the column headed “Listed Drug”: Fluticasone with formoterol substitute: Fluticasone propionate with formoterol
Schedule 1, entry for Fluticasone with salmeterol
omit from the column headed “Listed Drug”: Fluticasone with salmeterol substitute: Fluticasone propionate with salmeterol
Schedule 1, entry for Ganciclovir
(a)omit from the column headed “Circumstances” (all instances): C4990
(b)omit from the column headed “Circumstances” (all instances): C5025
(c)insert in numerical order in the column headed “Circumstances” (all instances): C9404 C9526
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(b)insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503
(c)omit from the column headed “Purposes”: P8059 P8060 P8073
(d)insert in numerical order in the column headed “Purposes”: P9414 P9428 P9429 P9503
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(b)insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503
(c)omit from the column headed “Purposes”: P8041 P8074
(d)insert in numerical order in the column headed “Purposes”: P9430 P9431
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(b)insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503
(c)omit from the column headed “Purposes”: P8059 P8060 P8073
(d)insert in numerical order in the column headed “Purposes”: P9414 P9428 P9429 P9503
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8041 C8059 C8060 C8073 C8074
(b)insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503
(c)omit from the column headed “Purposes”: P8041 P8074
(d)insert in numerical order in the column headed “Purposes”: P9430 P9431
Schedule 1, entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12
omit from the column headed “Responsible Person”: QA substitute: AF
Schedule 1, entry for Inotuzumab ozogamicin
omit from the column headed “Circumstances”: C8768 C8857 C8858 substitute: C9470 C9600 C9601
Schedule 1, entry for Insulin glargine
(a)insert in the column headed “Schedule Equivalent” for the brand “Lantus SoloStar”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column “Brand”:
| a | Semglee | AF | MP NP | 5 | 1 | 1 |
Schedule 1, entry for Interferon gamma-1b
(a)omit from the column headed “Circumstances”: C6286
(b)insert in numerical order in the column headed “Circumstances”: C9639
Schedule 1, entry for Irbesartan in the form Tablet 75 mg
omit:
| a | Irprestan 75 | ZP | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Irbesartan in the form Tablet 150 mg
omit:
| a | Irprestan 150 | ZP | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Irbesartan in the form Tablet 300 mg
omit:
| a | Irprestan 300 | ZP | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Lapatinib
omit from the column headed “Circumstances”: C6105 C7441 substitute: C9360 C9544
Schedule 1, entry for Letrozole
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Letrozole GH | HQ | MP NP | C5464 | 30 | 5 | 30 |
Schedule 1, entry for Levodopa with carbidopa in the form Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL [Maximum Quantity: 56; Number of Repeats: 5; Section 100/Prescriber Bag only: C(100)]
(a)omit from the column headed “Circumstances”: C6880
(b)insert in numerical order in the column headed “Circumstances”: C9405
Schedule 1, entry for Mannitol
(a)omit from the column headed “Circumstances”: C7349
(b)omit from the column headed “Circumstances”: C7364
(c)insert in numerical order in the column headed “Circumstances”: C9527 C9593
Schedule 1, entry for Meloxicam in each of the forms: Capsule 7.5 mg; and Capsule 15 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| MELOBIC | RF | MP NP | C4907 C4962 | 30 | 3 | 30 |
Schedule 1, entry for Mesalazine in the form Sachet containing granules, 500 mg per sachet
omit from the column headed “Circumstances”: C4824 substitute: C9444
Schedule 1, entry for Mesalazine in the form Sachet containing granules, 1 g per sachet
omit from the column headed “Circumstances”: C4824 substitute: C9444
Schedule 1, entry for Mesalazine in the form Sachet containing prolonged release granules, 1 g per sachet
omit from the column headed “Circumstances”: C4873 C4896 substitute: C9443 C9444
Schedule 1, entry for Mesalazine in the form Sachet containing granules, 1.5 g per sachet
omit from the column headed “Circumstances”: C4824 substitute: C9444
Schedule 1, entry for Mesalazine in the form Sachet containing prolonged release granules, 2 g per sachet
omit from the column headed “Circumstances”: C4873 C4896 substitute: C9443 C9444
Schedule 1, entry for Mesalazine in the form Sachet containing granules, 3 g per sachet
omit from the column headed “Circumstances”: C4824 substitute: C9444
Schedule 1, entry for Mesalazine in the form Sachet containing prolonged release granules, 4 g per sachet
omit from the column headed “Circumstances”: C4824 substitute: C9444
Schedule 1, entry for Mesalazine in the form Tablet 250 mg (enteric coated)
(a)omit from the column headed “Responsible Person”: AS substitute: GO
(b)omit from the column headed “Circumstances”: C4873 C4896 substitute: C9443 C9444
Schedule 1, entry for Mesalazine in the form Tablet 500 mg (enteric coated)
omit from the column headed “Circumstances”: C4873 C4896 substitute: C9443 C9444
Schedule 1, entry for Mesalazine in the form Tablet 500 mg (prolonged release)
omit from the column headed “Circumstances”: C4873 C4896 substitute: C9443 C9444
Schedule 1, entry for Mesalazine in the form Tablet 800 mg (enteric coated)
omit from the column headed “Circumstances”: C4824 substitute: C9510
Schedule 1, entry for Mesalazine in the form Tablet 1 g (enteric coated)
omit from the column headed “Circumstances”: C4873 C4896 substitute: C9443 C9444
Schedule 1, entry for Mesalazine in the form Tablet 1 g (prolonged release)
omit from the column headed “Circumstances”: C4873 C4896 substitute: C9443 C9444
Schedule 1, entry for Mesalazine in the form Tablet 1.2 g (prolonged release)
omit from the column headed “Circumstances”: C4824 substitute: C9444
Schedule 1, entry for Methylprednisolone in the form Cream containing methylprednisolone aceponate 1 mg per g, 15 g
omit from the column headed “Responsible Person”: BN substitute: LO
Schedule 1, entry for Methylprednisolone in the form Lotion containing methylprednisolone aceponate 1 mg per g, 20 g
omit from the column headed “Responsible Person”: BN substitute: LO
Schedule 1, entry for Methylprednisolone in the form Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g
omit from the column headed “Responsible Person”: BN substitute: LO
Schedule 1, entry for Methylprednisolone in the form Ointment containing methylprednisolone aceponate 1 mg per g, 15 g
omit from the column headed “Responsible Person”: BN substitute: LO
Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | MONTELAIR 4 | RF | MP NP | C6666 | 28 | 5 | 28 |
Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | MONTELAIR 5 | RF | MP NP | C6674 C7781 | 28 | 5 | 28 |
Schedule 1, entry for Natalizumab
(a)omit from the column headed “Circumstances”: C6845
(b)omit from the column headed “Circumstances”: C7769
(c)insert in numerical order in the column headed “Circumstances”: C9406
Schedule 1, entry for Nicorandil in each of the forms: Tablets 10 mg, 60; and Tablets 20 mg, 60
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APO-Nicorandil | TX | MP NP | 1 | 5 | 1 |
Schedule 1, entry for Norfloxacin
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APO-Norfloxacin | TX | MP NP | C5744 C5806 | 14 | 1 | 14 |
Schedule 1, entry for Ocrelizumab
(a)omit from the column headed “Circumstances”: C7412
(b)omit from the column headed “Circumstances”: C7771
(c)insert in numerical order in the column headed “Circumstances”: C9523 C9635
Schedule 1, entry for Ocriplasmin
insert as first entry:
| Solution for intravitreal injection 0.375 mg in 0.3 mL | Injection | Jetrea RTU | IJ | MP | C9363 | 1 | 0 | 1 |
Schedule 1, entry for Ocriplasmin in the form Solution concentrate for intravitreal injection 0.5 mg in 0.2 mL
omit from the column headed “Circumstances”: C6601 substitute: C9363
Schedule 1, entry for Ondansetron in the form I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL
(a)omit from the column headed “Schedule Equivalent” for the brand “Ondansetron Alphapharm”: a
(b)omit:
| a | Onsetron | ZP | MP NP | C4077 C4092 | 1 | 0 | 1 |
| MP | C5749 | 1 | 0 | 1 | (C100) |
Schedule 1, entry for Ondansetron in the form I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
(a)omit from the column headed “Schedule Equivalent” for the brand “Ondansetron Alphapharm”: a
(b)omit:
| a | Onsetron | ZP | MP NP | C4077 C4092 | 1 | 0 | 1 |
| MP | C5749 | 1 | 0 | 1 | (C100) |
Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]
omit:
| a | Onsetron 4 | ZP | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 |
| MP | C5778 | 4 | 0 | 4 | C(100) |
Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]
omit:
| a | Onsetron 4 | ZP | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 |
Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]
omit:
| a | Onsetron 8 | ZP | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 |
| MP | C5778 | 4 | 0 | 4 | C(100) |
Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]
omit:
| a | Onsetron 8 | ZP | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 |
Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg
(a)omit from the column headed “Responsible Person”: QA substitute: AF
(b)omit from the column headed “Responsible Person”: FM substitute: AL
Schedule 1, entry for Peginterferon alfa-2a in the form Injection 135 micrograms in 0.5 mL single use pre-filled syringe [Maximum Quantity: 8; Number of Repeats: 5; Section 100/Prescriber Bag only: C(100)]
(a)omit from the column headed “Purposes”: P5016
(b)insert in numerical order in the column headed “Purposes”: P9603
(c)omit from the column headed “Maximum Quantity”: CN5016
(d)insert in numerical order in the column headed “Maximum Quantity”: CN9603
(e)omit from the column headed “Number of Repeats”: CN5016
(f)insert in numerical order in the column headed “Number of Repeats”: CN9603
Schedule 1, entry for Peginterferon alfa-2a in the form Injection 180 micrograms in 0.5 mL single use pre-filled syringe [Maximum Quantity: 8; Number of Repeats: 5; Section 100/Prescriber Bag only: C(100)]
(a)omit from the column headed “Purposes”: P5016
(b)insert in numerical order in the column headed “Purposes”: P9603
(c)omit from the column headed “Maximum Quantity”: CN5016
(d)insert in numerical order in the column headed “Maximum Quantity”: CN9603
(e)omit from the column headed “Number of Repeats”: CN5016
(f)insert in numerical order in the column headed “Number of Repeats”: CN9603
Schedule 1, entry for Pertuzumab
omit from the column headed “Circumstances”: C4971 C5013 C5023 substitute: C9516 C9517 C9579
Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 250 mg phenoxymethylpenicillin (as potassium)
omit from the column headed “Responsible Person” for the brand “Cilicaine VK” (twice occurring): FM substitute: AF
Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 500 mg phenoxymethylpenicillin (as potassium)
omit from the column headed “Responsible Person”: FM substitute: AF
Schedule 1, entry for Phenoxymethylpenicillin in each of the forms: Tablet 250 mg phenoxymethylpenicillin (as potassium); and Tablet 500 mg phenoxymethylpenicillin (as potassium)
omit from the column headed “Responsible Person”: QA substitute: AF
Schedule 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C7901 C7914 C7926
(b)insert in numerical order in the column headed “Circumstances”: C9465 C9466 C9614
(c)omit from the column headed “Purposes”: P7901 P7914 P7926
(d)insert in numerical order in the column headed “Purposes”: P9465 P9466 P9614
Schedule 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7901 C7914 C7926
(b)insert in numerical order in the column headed “Circumstances”: C9465 C9466 C9614
Schedule 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C7901 C7914 C7926
(b)insert in numerical order in the column headed “Circumstances”: C9465 C9466 C9614
(c)omit from the column headed “Purposes”: P7901 P7914 P7926
(d)insert in numerical order in the column headed “Circumstances”: P9465 P9466 P9614
Schedule 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7901 C7914 C7926
(b)insert in numerical order in the column headed “Circumstances”: C9465 C9466 C9614
Schedule 1, entry for Procaine benzylpenicillin
omit from the column headed “Responsible Person”: QA substitute: AF
Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)
omit:
| a | Parzol 10 | ZP | MP NP | C5444 C5512 | 28 | 5 | 28 |
Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)
(a)omit:
| a | Parzol 20 | ZP | MP NP | C8774 C8775 C8776 C8780 | P8774 P8775 | 30 | 1 | 30 |
(b)omit:
| a | Parzol 20 | ZP | MP NP | C8774 C8775 C8776 C8780 | P8776 P8780 | 30 | 5 | 30 |
Schedule 1, entry for Rifabutin
(a)omit from the column headed “Circumstances”: C6349
(b)omit from the column headed “Circumstances”: C6361
(c)insert in numerical order in the column headed “Circumstances”: C9560 C9622
Schedule 1, entry for Rituximab
substitute:
| Rituximab | Solution for I.V. infusion 100 mg in 10 mL | Injection | a | Mabthera | RO | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | PB(100) |
| a | Riximyo | SZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | PB(100) | |||
| Mabthera | RO | MP | C7399 C7400 C9451 C9542 | See Note 3 | See Note 3 | 2 | PB(100) | |||||
| Riximyo | SZ | MP | C7399 C7400 C9451 C9542 | See Note 3 | See Note 3 | 2 | PB(100) | |||||
| Solution for I.V. infusion 500 mg in 50 mL | Injection | a | Mabthera | RO | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | PB(100) | |
| a | Riximyo | SZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | PB(100) | |||
| Mabthera | RO | MP | C7399 C7400 C9451 C9542 | See Note 3 | See Note 3 | 1 | PB(100) | |||||
| Riximyo | SZ | MP | C7399 C7400 C9451 C9542 | See Note 3 | See Note 3 | 1 | PB(100) | |||||
| Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL | Injection | Mabthera SC | RO | MP | C6011 C6161 C7399 C7400 | P7399 | 1 | 5 | 1 | |||
| MP | C6011 C6161 C7399 C7400 | P7400 | 1 | 6 | 1 | |||||||
| MP | C6011 C6161 C7399 C7400 | P6011 | 1 | 7 | 1 | |||||||
| MP | C6011 C6161 C7399 C7400 | P6161 | 1 | 11 | 1 |
Schedule 1, entry for Rivastigmine in the form Transdermal patch 9 mg
(a)omit from the column headed “Schedule Equivalent” for the brand “Exelon Patch 5”: a
(b)omit:
| a | Rivastigmelon Patch 5 | AF | MP NP | C4219 C4220 C4224 | 30 | 5 | 30 |
Schedule 1, entry for Rivastigmine in the form Transdermal patch 18 mg
(a)omit from the column headed “Schedule Equivalent” for the brand “Exelon Patch 10”: a
(b)omit:
| a | Rivastigmelon Patch 10 | AF | MP NP | C4219 C4220 C4224 | 30 | 5 | 30 |
Schedule 1, entry for Rivastigmine in the form Transdermal patch 27 mg
(a)omit from the column headed “Schedule Equivalent” for the brand “Exelon Patch 15”: a
(b)omit:
| a | Rivastigmelon Patch 15 | AF | MP NP | C4219 C4220 C4224 | 30 | 5 | 30 |
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8061 C8074 C8085 C8100 C8105 C8120
(b)insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503
(c)omit from the column headed “Purposes”: P8120
(d)insert in numerical order in the column headed “Purposes”: P9429
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8061 C8074 C8085 C8100 C8105 C8120
(b)insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503
(c)omit from the column headed “Purposes”: P8061 P8074 P8100
(d)insert in numerical order in the column headed “Purposes”: P9430 P9431
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8061 C8074 C8085 C8100 C8105 C8120
(b)insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8061 C8074 C8085 C8100 C8105 C8120
(b)insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8061 C8074 C8085 C8100 C8105 C8120
(b)insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503
(c)omit from the column headed “Purposes”: P8085 P8105
(d)insert in numerical order in the column headed “Purposes”: P9414 P9428 P9503
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 8; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8061 C8074 C8085 C8100 C8105 C8120
(b)insert in numerical order in the column headed “Circumstances”: C9414 C9428 C9429 C9430 C9431 C9503
Schedule 1, entry for Somatropin
omit:
| Injection 10 mg (30 i.u.) vial with diluent (with preservative) | Injection | Zomacton | FP | MP | C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8376 C8377 C8380 C8393 C8394 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8424 C8425 C8426 C9221 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg (once daily prolonged release)
substitute:
| Capsule 0.5 mg (once daily prolonged release) | Oral | ADVAGRAF XL | LQ | MP | 30 | 3 | 30 |
| MP | P5569 P5602 | 60 CN5569 CN5602 | 5 CN5569 CN5602 | 30 | C(100) |
Schedule 1, entry for Tacrolimus in the form Capsule 1 mg (once daily prolonged release)
substitute:
| Capsule 1 mg (once daily prolonged release) | Oral | ADVAGRAF XL | LQ | MP | 60 | 3 | 60 |
| MP | P5569 P5602 | 120 CN5569 CN5602 | 5 CN5569 CN5602 | 60 | C(100) |
Schedule 1, entry for Tacrolimus in the form Capsule 5 mg (once daily prolonged release)
substitute:
| Capsule 5 mg (once daily prolonged release) | Oral | ADVAGRAF XL | LQ | MP | 30 | 3 | 30 |
| MP | P5569 P5602 | 60 CN5569 CN5602 | 5 CN5569 CN5602 | 30 | C(100) |
Schedule 1, after entry for Tapentadol in the form Tablet (modified release) 250 mg (as hydrochloride)
insert:
| Teduglutide | Powder for injection 5 mg with diluent | Injection | Revestive | ZI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 28 | D(100) |
Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 1]
(a)omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135
(b)insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609
(c)omit from the column headed “Purposes”: P9052 P9096 P9133 P9134 P9135 substitute: P9382 P9383 P9384 P9474 P9477 P9520
Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135
(b)insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609
(c)omit from the column headed “Purposes”: P9129 P9130 substitute: P9384 P9609
Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135
(b)insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609
(c)omit from the column headed “Purposes”: P9046 P9047 P9048
(d)insert in numerical order in the column headed “Purposes”: P9386 P9390 P9391 P9478
Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135
(b)insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609
(c)omit from the column headed “Purposes”: P9049 P9131
(d)insert in numerical order in the column headed “Purposes”: P9380 P9553
Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 6]
(a)omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135
(b)insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609
Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of
Repeats: 1]
(a)omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135
(b)insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609
(c)omit from the column headed “Purposes”: P9052 P9096 P9133 P9134 P9135 substitute: P9382 P9383 P9384 P9474 P9477 P9520
Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of
Repeats: 2]
(a)omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135
(b)insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609
(c)omit from the column headed “Purposes”: P9129 P9130 substitute: P9384 P9609
Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of
Repeats: 3]
(a)omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135
(b)insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609
(c)omit from the column headed “Purposes”: P9046 P9047 P9048
(d)insert in numerical order in the column headed “Purposes”: P9386 P9390 P9391 P9478
Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of
Repeats: 5]
(a)omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135
(b)insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609
(c)omit from the column headed “Purposes”: P9049 P9131
(d)insert in numerical order in the column headed “Purposes”: P9380 P9553
Schedule 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of
Repeats: 6]
(a)omit from the column headed “Circumstances”: C9046 C9047 C9048 C9049 C9052 C9096 C9129 C9130 C9131 C9133 C9134 C9135
(b)insert in numerical order in the column headed “Circumstances”: C9380 C9382 C9383 C9384 C9386 C9390 C9391 C9474 C9477 C9478 C9520 C9553 C9609
Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 100 mg
omit:
| a | Lodam SR 100 | ZP | MP NP | C5822 | 20 | 0 | 20 |
Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 150 mg
omit:
| a | Lodam SR 150 | ZP | MP NP | C5822 | 20 | 0 | 20 |
Schedule 1, entry for Trastuzumab in the form Powder for I.V. infusion 60 mg
omit from the column headed “Circumstances”: C4083 C4093 C4104 C4142 C4143 C4156 C5024 C5032 C5041 C5834 C5844 C7718 C7746 substitute: C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628
Schedule 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg
(a)omit from the column headed “Circumstances” for the brand “Herceptin”: C4083 C4093 C4104 C4142 C4143 C4156 C5024 C5032 C5041 C5834 C5844 C7718 C7746 substitute: C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628
(b)omit from the column headed “Circumstances” for the brand “Ogivri”: C4083 C4093 C4104 C4142 C4143 C4156 C5024 C5032 C5041 C5834 C5844 C7718 C7746 substitute: C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628
Schedule 1, entry for Trastuzumab in the form Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL [Maximum
Quantity: 1; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C5024 C5032 C5041 C6060 C6061 C6062 C7717 substitute: C9351 C9353 C9462
(b)omit from the column headed “Purposes”: P5032 P6060 P7717 substitute: P9353
Schedule 1, entry for Trastuzumab in the form Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL [Maximum
Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C5024 C5032 C5041 C6060 C6061 C6062 C7717 substitute: C9351 C9353 C9462
(b)omit from the column headed “Purposes”: P5024 P5041 P6061 P6062 substitute: P9351 P9462
Schedule 1, entry for Trastuzumab emtansine in each of the forms: Powder for I.V. infusion 100 mg; and Powder for I.V. infusion 160 mg
omit from the column headed “Circumstances”: C4978 C4986 C6096 C6129 substitute: C9359 C9577 C9599
Schedule 1, entry for Warfarin in the form Tablet containing warfarin sodium 1 mg
(a)omit from the column headed “Responsible Person”: QA substitute: GO
(b)omit from the column headed “Responsible Person”: FM substitute: GT
Schedule 1, entry for Warfarin in the form Tablet containing warfarin sodium 2 mg
omit from the column headed “Responsible Person”: QA substitute: GO
Schedule 1, entry for Warfarin in the form Tablet containing warfarin sodium 3 mg
omit from the column headed “Responsible Person”: FM substitute: GT
Schedule 1, entry for Warfarin in the form Tablet containing warfarin sodium 5 mg
(a)omit from the column headed “Responsible Person”: QA substitute: GO
(b)omit from the column headed “Responsible Person”: FM substitute: GT
Schedule 1, entry for Zoledronic acid
omit:
| Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL vial | Injection | Claris Lifesciences Zoledronic Acid | DZ | MP | C5605 C5703 C5704 C5735 C9236 C9269 C9270 C9291 | 5 | 0 | 5 | PB(100) |
Schedule 3, after details relevant to Responsible Person code MK
insert:
MQ Alphapharm Pty Ltd 93 002 359 739
Schedule 4, Part 1, entry for Abatacept
(a)omit entry for circumstances code “C8651” and substitute:
| C8651 | P8651 | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND Patient must not receive more than 16 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion. Up to a maximum of 4 repeats will be authorised. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats. Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats. It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
(b)omit entry for circumstances code “C8652” and substitute:
| C8652 | P8652 | Severe active rheumatoid arthritis Initial treatment - Initial 3 (re-commencement of treatment after a break in biological medicine of more than 24 months) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats. Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats. It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
(c)omit entry for circumstances code “C8655” and substitute:
| C8655 | P8655 | Severe active rheumatoid arthritis Continuing treatment Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Where a response assessment is not provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
(e)omit entry for circumstances code “C9157” and substitute:
| C9157 | P9157 | Severe psoriatic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. 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 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Trastuzumab
substitute:
| Trastuzumab | C9349 | Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, a new loading dose may be required. | Compliance with Authority Required procedures - Streamlined Authority Code 9349 |
| C9351 | P9351 | Early HER2 positive breast cancer 3 weekly treatment regimen Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9351 |
| C9353 | P9353 | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND The treatment must not be in combination with nab-paclitaxel; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9353 |
| C9354 | Early HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9354 | |
| C9356 | Early HER2 positive breast cancer Initial treatment (weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9356 | |
| C9461 | Early HER2 positive breast cancer Continuing treatment (3 weekly regimen) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 9461 | |
| C9462 | P9462 | Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. | Compliance with Authority Required procedures - Streamlined Authority Code 9462 |
| C9571 | Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. | Compliance with Authority Required procedures - Streamlined Authority Code 9571 | |
| C9573 | Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; AND Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; AND Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; AND Patient must commence treatment in combination with platinum based chemotherapy and capecitabine; OR Patient must commence treatment in combination with platinum based chemotherapy and 5 fluorouracil; AND Patient must not have previously received this drug for this condition; AND Patient must not have received prior chemotherapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9573 | |
| C9628 | Early HER2 positive breast cancer Continuing treatment (weekly regimen) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 9628 |
Schedule 4, Part 1, entry for Trastuzumab emtansine
substitute:
| Trastuzumab emtansine | C9359 | Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be as monotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. The treatment must not exceed a lifetime total of one continuous course. | Compliance with Authority Required procedures |
| C9577 | Metastatic (Stage IV) HER2 positive breast cancer Grandfathering treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 July 2015; OR Patient must have received non-PBS-subsidised trastuzumab for this condition before 1 July 2015; OR Patient must have received PBS-subsidised lapatinib for this condition before 1 July 2015; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be as monotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for treatment must be made in writing and must include a completed authority prescription form. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA) during treatment. | Compliance with Written Authority Required procedures | |
| C9599 | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be as monotherapy; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Late stage metastatic breast cancer Initial PBS authority application form which includes: (i) a copy of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) and tick a box to state the person has Stage IV disease; (ii) dates of treatment with trastuzumab and pertuzumab; and (iii) date of demonstration of progression whilst on treatment with trastuzumab and pertuzumab; or (iv) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Ustekinumab
omit entry for circumstances code “C9175” and substitute:
| C9175 | P9175 | Severe psoriatic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. 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 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Zoledronic acid
(a)omit:
| C9236 | Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 9236 |
(b)omit:
| C9269 | Multiple myeloma | Compliance with Authority Required procedures - Streamlined Authority Code 9269 |
| C9270 | Bone metastases The condition must be due to breast cancer. | Compliance with Authority Required procedures - Streamlined Authority Code 9270 |
| C9291 | Bone metastases The condition must be due to castration-resistant prostate cancer. | Compliance with Authority Required procedures - Streamlined Authority Code 9291 |
Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-15475]
insert in alphabetical order in the column headed “Brand”: Clopidogrel Sandoz Pharma
Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-17110]
insert in alphabetical order in the column headed “Brand”: Clopidogrel Sandoz Pharma
Schedule 5, after entry for Fentanyl in the form Transdermal patch 2.1 mg [GRP-15898]
insert:
| Filgrastim | GRP-23379 | Injection 300 micrograms in 0.5 mL single-use pre-filled syringe | Injection | Neupogen Nivestim Zarzio |
| Injection 300 micrograms in 1 mL | Injection | Neupogen | ||
| GRP-23385 | Injection 480 micrograms in 0.5 mL single-use pre-filled syringe | Injection | Neupogen Nivestim Zarzio | |
| Injection 480 micrograms in 1.6 mL | Injection | Neupogen |
Schedule 5, entry for Meloxicam in the form Capsule 15 mg [GRP-15468]
insert in alphabetical order in the column headed “Brand”: MELOBIC
Schedule 5, entry for Meloxicam in the form Capsule 7.5 mg [GRP-15658]
insert in alphabetical order in the column headed “Brand”: MELOBIC
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0
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