National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 11) (PB 107 of 2015) (Cth)
PB 107 of 2015
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 11)
National Health Act 1953
I, PENNY SHAKESPEARE, First Assistant Secretary, Pharmaceutical Benefits 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 25th November 2015
PENNY SHAKESPEARE
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 11).
(2) This Instrument may also be cited as PB 107 of 2015.
2 Commencement
This Instrument commences on 1 December 2015.
3 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
After Section 8
insert:
8A Schedule equivalent
(1) For subsection 85(6A) of the Act:
(a) a brand of a pharmaceutical item with an ‘a’ located in the column headed ‘Schedule Equivalent’ in Schedule 1, is to be treated as equivalent to another brand of that pharmaceutical item that also has an ‘a’ located in the column headed ‘Schedule Equivalent’ in Schedule 1;
(b) where paragraph (a) applies to a brand of a pharmaceutical item, a brand of the same pharmaceutical item with a ‘b’ in the column headed ‘Schedule equivalent’ in Schedule 1, is to be treated as equivalent to another brand of that pharmaceutical item that also has a ‘b’ located in the column headed ‘Schedule Equivalent’ in Schedule 1; and
(c) where a brand of a pharmaceutical item appears in Schedule 5, that brand is to be treated as equivalent to any brand of any pharmaceutical item that is in the same schedule equivalent group as that brand in Schedule 5.
Schedule 1, columns
insert, between column headed “Manner of Administration” and column headed “Brand”, a column headed:
Schedule Equivalent
Schedule 1, entry for Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg
omit from the column headed “Circumstances” (all instances): C1363 C1366 substitute: C5727 C5789
Schedule 1, after entry for Aclidinium
insert:
| Aclidinium with eformoterol | Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses | Inhalation by mouth | Brimica Genuair | FK | MP NP | C5763 | 1 | 5 | 1 |
Schedule 1, entry for Albendazole in the form Tablet 200 mg [Maximum Quantity: 6; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C1388 C1525 C2446 C3241 substitute: C5680 C5712 C5797 C5817
(b)omit from the column headed “Purposes”: P1388 P2446 P3241 substitute: P5712 P5797 P5817
Schedule 1, entry for Albendazole in the form Tablet 200 mg [Maximum Quantity: 6; Number of Repeats: 1]
(a)omit from the column headed “Circumstances”: C1388 C1525 C2446 C3241 substitute: C5680 C5712 C5797 C5817
(b)omit from the column headed “Purposes”: P1525 substitute: P5680
Schedule 1, entry for Albendazole in the form Tablet 400 mg
omit from the column headed “Circumstances”: C1496 substitute: C5607
Schedule 1, entry for Alprazolam in each of the forms: Tablet 250 micrograms; Tablet 500 micrograms; Tablet 1 mg; and Tablet 2 mg
omit from the column headed “Circumstances” (all instances): C1975 substitute: C5608
Schedule 1, entry for Amino acid formula without phenylalanine in each of the forms: Capsules 500 mg, 200 (Phlexy-10); Tablets 1 g,
75 (Phlexy-10); and Sachets containing oral powder 20 g, 30 (Phlexy-10 Drink Mix)
omit from the column headed “Circumstances”: C1286 substitute: C4295
Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine
omit:
| Sachets containing oral powder 29 g, 30 (PKU Anamix Junior) | Oral | PKU Anamix Junior | SB | MP NP | C4295 | 4 | 5 | 1 |
Schedule 1, entry for Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine
omit from the column headed “Circumstances”: C1286 substitute: C4295
Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine
omit:
| Sachets containing oral powder 29 g, 30 (TYR Anamix Junior) | Oral | TYR Anamix Junior | SB | MP NP | C5533 | 4 | 5 | 1 |
Schedule 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
omit:
| Sachets containing oral powder 29 g, 30 (MSUD Anamix Junior) | Oral | MSUD Anamix Junior | SB | MP NP | C5571 | 4 | 5 | 1 |
Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 100 mg
omit from the column headed “Circumstances” (twice occurring): C1350 substitute: C5665
Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg
(a)omit:
| Amiodarone Actavis | EA | MP NP | C1350 | 30 | 5 | 30 |
(b)omit from the column headed “Circumstances” (all instances): C1350 substitute: C5665
Schedule 1, entry for Amisulpride in each of the forms: Tablet 100 mg; Tablet 200 mg; Tablet 400 mg; and Oral solution 100 mg per mL,
60 mL
omit from the column headed “Circumstances” (all instances): C1589 substitute: C4246
Schedule 1, entry for Amlodipine with Atorvastatin in each of the forms: Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium); Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium); Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium); Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium); Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium); Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium); Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium); and Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)
omit from the column headed “Circumstances” (all instances): C2449 C2450 C2451 substitute: C5619 C5694 C5750 C5751 C5787 C5788
Schedule 1, entry for Ampicillin in the form Powder for injection 500 mg (as sodium)
omit from the column headed “Responsible Person” for the brand “Ibimicyn” (twice occurring): EA substitute: JU
Schedule 1, entry for Ampicillin in the form Powder for injection 1 g (as sodium)
omit from the column headed “Responsible Person” for the brand “Ibimicyn” (twice occurring): EA substitute: JU
Schedule 1, entry for Artemether with lumefantrine in the form Tablet 20 mg-120 mg
omit from the column headed “Circumstances”: C3210 substitute: C5767
Schedule 1, entry for Artemether with lumefantrine in the form Tablet (dispersible) 20 mg-120 mg
omit from the column headed “Circumstances”: C3551 substitute: C5632
Schedule 1, entry for Asenapine in each of the forms: Sublingual wafer 5 mg (as maleate); and Sublingual wafer 10 mg (as maleate)
omit from the column headed “Circumstances”: C1589 C3935 C3936 substitute: C4246 C5719 C5773
Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances) [Authorised Prescriber MP]: C1540 C3047 substitute: C4238 C4263
(b)omit from the column headed “Purposes” (all instances): P1540 substitute: P4263
(c)omit from the column headed “Circumstances” (all instances) [Authorised Prescriber NP]: C1540 substitute: C4263
Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
(a)omit from the column headed “Circumstances” (all instances): C1540 C3047 substitute: C4238 C4263
(b)omit from the column headed “Purposes” (all instances): P3047 substitute: P4238
Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances) [Authorised Prescriber MP]: C1540 C3047 substitute: C4238 C4263
(b)omit from the column headed “Purposes” (all instances): P1540 substitute: P4263
(c)omit from the column headed “Circumstances” (all instances) [Authorised Prescriber NP]: C1540 substitute: C4263
Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
(a)omit from the column headed “Circumstances” (all instances): C1540 C3047 substitute: C4238 C4263
(b)omit from the column headed “Purposes” (all instances): P3047 substitute: P4238
Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances) [Authorised Prescriber MP]: C1540 C3047 substitute: C4238 C4263
(b)omit from the column headed “Purposes” (all instances): P1540 substitute: P4263
(c)omit from the column headed “Circumstances” (all instances) [Authorised Prescriber NP]: C1540 substitute: C4263
Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
(a)omit from the column headed “Circumstances” (all instances): C1540 C3047 substitute: C4238 C4263
(b)omit from the column headed “Purposes” (all instances): P3047 substitute: P4238
Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances) [Authorised Prescriber MP]: C1540 C3047 substitute: C4238 C4263
(b)omit from the column headed “Purposes” (all instances): P1540 substitute: P4263
(c)omit from the column headed “Circumstances” (all instances) [Authorised Prescriber NP]: C1540 substitute: C4263
Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
(a)omit from the column headed “Circumstances” (all instances): C1540 C3047 substitute: C4238 C4263
(b)omit from the column headed “Purposes” (all instances): P3047 substitute: P4238
Schedule 1, entry for Atovaquone
omit from the column headed “Circumstances”: C1433 substitute: C5609
Schedule 1, entry for Atovaquone with proguanil
omit from the column headed “Circumstances”: C3135 substitute: C5714
Schedule 1, after entry for Aurothiomalate in the form Injection containing sodium aurothiomalate 50 mg
insert:
| Axitinib | Tablet 1 mg | Oral | Inlyta | PF | MP | C5674 C5733 | P5733 | 56 | 2 | 28 |
| MP | C5674 C5733 | P5674 | 56 | 5 | 28 | |||||
| Tablet 5 mg | Oral | Inlyta | PF | MP | C5674 C5733 | P5733 | 56 | 2 | 28 | |
| MP | C5674 C5733 | P5674 | 56 | 5 | 28 |
Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances” (all instances): C1405 C1838 C1839 substitute: C5637 C5718 C5772
(b)omit from the column headed “Purposes” (all instances): P1838 P1839 substitute: P5718 P5772
Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances” (all instances): C1405 C1838 C1839 substitute: C5637 C5718 C5772
(b)omit from the column headed “Purposes” (all instances): P1405 substitute: P5637
Schedule 1, entry for Azithromycin in the form Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL
omit from the column headed “Circumstances”: C1405 substitute: C5637
Schedule 1, after entry for Benztropine in the form Injection containing benztropine mesylate 2 mg in 2 mL
insert in the columns in the order indicated:
| Injection containing benztropine mesylate 2 mg in 2 mL vial | Injection | Benztropine Omega | FK | MP NP PDP | 10 | 0 | 10 |
Schedule 1, entry for Benzydamine in the form Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL [Maximum Quantity: 1; Number of Repeats: 0]
(a)omit from the column headed “Circumstances” [Authorised Prescriber MP NP]: C1669 C3634 C3635 substitute: C5622 C5651 C5672
(b)omit from the column headed “Purposes”: P3635 substitute: P5651
(c)omit from the column headed “Circumstances” [Authorised Prescriber PDP]: C1669 substitute: C5732
Schedule 1, entry for Benzydamine in the form Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL [Maximum Quantity: 1; Number of Repeats: 1]
(a)omit from the column headed “Circumstances”: C1669 C3634 C3635 substitute: C5622 C5651 C5672
(b)omit from the column headed “Purposes”: P1669 substitute: P5672
Schedule 1, entry for Benzydamine in the form Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL [Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C1669 C3634 C3635 substitute: C5622 C5651 C5672
(b)omit from the column headed “Purposes”: P3634 substitute: P5622
Schedule 1, entry for Bicalutamide
omit from the column headed “Circumstances” (all instances): C3674 substitute: C5729
Schedule 1, entry for Bisacodyl
substitute:
| Bisacodyl | Suppositories 10 mg, 10 | Rectal | a | Dulcolax | BY | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 3 | 0 | 1 |
| a | Petrus Bisacodyl Suppositories | PP | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 3 | 0 | 1 | |||
| a | Dulcolax | BY | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 3 | 3 | 1 | |||
| a | Petrus Bisacodyl Suppositories | PP | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 3 | 3 | 1 | |||
| a | Dulcolax | BY | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 3 | 5 | 1 | |||
| a | Petrus Bisacodyl Suppositories | PP | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 3 | 5 | 1 | |||
| Dulcolax | BY | MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | |||
| Petrus Bisacodyl Suppositories | PP | MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | |||
| Suppositories 10 mg, 12 | Rectal | Petrus Bisacodyl Suppositories | PP | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 3 | 0 | 1 | ||
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 3 | 3 | 1 | ||||||
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 3 | 4 | 1 | ||||||
| MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | |||||
| Enemas 10 mg in 5 mL, 25 | Rectal | Bisalax | AS | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 1 | 0 | 1 | ||
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 1 | 2 | 1 | ||||||
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 1 | 3 | 1 | ||||||
| MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | |||||
| Tablet 5 mg | Oral | Lax-Tab | AE | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 200 | 0 | 200 | ||
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 200 | 2 | 200 | ||||||
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 200 | 3 | 200 | ||||||
| MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 200 | C(100) |
Schedule 1, after entry for Brinzolamide [Brand: BrinzoQuin]
insert:
| Brinzolamide with brimonidine | Eye drops 10 mg brinzolamide with 2 mg brimonidine tartrate per mL, 5 mL | Application to the eye | Simbrinza 1%/0.2% | AQ | MP | C5630 | 1 | 5 | 1 |
| AO | C5038 | 1 | 5 | 1 |
Schedule 1, entry for Captopril in each of the forms: Tablet 12.5 mg; Tablet 25 mg; and Tablet 50 mg
omit:
| GenRx Captopril | GX | MP NP | 90 | 5 | 90 |
Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate)
(a)omit:
| GenRx Cefaclor CD | GX | PDP | 10 | 0 | 10 |
(b)omit:
| GenRx Cefaclor CD | GX | MP | 10 | 1 | 10 |
Schedule 1, entry for Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
(a)omit:
| GenRx Cefaclor | GX | PDP | 1 | 0 | 1 |
(b)omit:
| GenRx Cefaclor | GX | MP | 1 | 1 | 1 |
Schedule 1, entry for Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
(a)omit:
| GenRx Cefaclor | GX | PDP | 1 | 0 | 1 |
(b)omit:
| GenRx Cefaclor | GX | MP | 1 | 1 | 1 |
Schedule 1, entry for Ceftriaxone in the form Powder for injection 500 mg (as sodium) [Maximum Quantity: 5; Number of Repeats: 0]
(a)omit from the column headed “Brand”: Ceftriaxone-AFT
(b)omit from the column headed “Responsible Person”: AE
Schedule 1, entry for Ceftriaxone in the form Powder for injection 2 g (as sodium)
omit:
| Ceftriaxone Sandoz | SZ | MP NP | C1169 C1846 C1847 | 5 | 0 | 1 |
Schedule 1, entry for Ciprofloxacin in the form Tablet 250 mg (as hydrochloride)
omit from the column headed “Circumstances” (all instances): C1143 C1431 C1432 C1572 C1573
substitute: C5614 C5615 C5666 C5687 C5688 C5689 C5722 C5780
Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)
omit from the column headed “Circumstances” (all instances): C1431 C1432 C1572 C1573
substitute: C5614 C5615 C5687 C5688 C5689 C5722 C5780
Schedule 1, entry for Clarithromycin in the form Powder for oral liquid 250 mg per 5 mL, 50 mL
omit from the column headed “Circumstances”: C3016 C3017 substitute: C5638 C5663
Schedule 1, entry for Clindamycin
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Clindamyk | AF | MP NP MW | C5470 | 24 | 0 | 24 |
| PDP | C5487 | 24 | 0 | 24 |
Schedule 1, entry for Dapagliflozin
omit from the column headed “Circumstances”: C5062 substitute: C5629
Schedule 1, entry for Dapagliflozin with metformin in each of the forms: Tablet (modified release) containing 5 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride; Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 500 mg metformin hydrochloride; and Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride
omit from the column headed “Circumstances”: C5455 C5527 substitute: C5631 C5657 C5739 C5798
Schedule 1, entry for Degarelix in the form Powder for injection 80 mg (as acetate), injection set
omit from the column headed “Circumstances”: C3229 substitute: C5646
Schedule 1, entry for Degarelix in the form Powder for injection 120 mg (as acetate), 2, injection set
omit from the column headed “Circumstances”: C3229 substitute: C5786
Schedule 1, entry for Dornase Alfa
omit from the column headed “Circumstances”: C4288 C4290 C4291 C4296 C4297 C4298 C4300 C4301
substitute: C5634 C5635 C5715 C5740 C5768 C5800
Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 5 mg
(a)omit:
| Chem mart Enalapril | CH | MP NP | 30 | 5 | 30 |
(b)omit:
| GenRx Enalapril | GX | MP NP | 30 | 5 | 30 |
(c)omit:
| Terry White Chemists Enalapril | TW | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 10 mg
(a)omit:
| Chem mart Enalapril | CH | MP NP | 30 | 5 | 30 |
(b)omit:
| GenRx Enalapril | GX | MP NP | 30 | 5 | 30 |
(c)omit:
| Terry White Chemists Enalapril | TW | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 20 mg
(a)omit:
| Chem mart Enalapril | CH | MP NP | 30 | 5 | 30 |
(b)omit:
| GenRx Enalapril | GX | MP NP | 30 | 5 | 30 |
(c)omit:
| Terry White Chemists Enalapril | TW | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Epirubicin
omit:
| Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL | Injection/ intravesical | Epirubicin Actavis 10 | UA | MP | See Note 3 | See Note 3 | 1 | D(100) |
| Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL | Injection/ intravesical | Epirubicin Actavis 20 | UA | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Esomeprazole and clarithromycin and amoxycillin
omit from the column headed “Circumstances”: C1096 substitute: C5683
Schedule 1, entry for Everolimus in the form Tablet 0.25 mg [Maximum Quantity: 120; Number of Repeats: 5]
omit from the column headed “Circumstances”: C5567 C5599 substitute: C5794 C5795
Schedule 1, entry for Everolimus in the form Tablet 0.5 mg [Maximum Quantity: 120; Number of Repeats: 5]
omit from the column headed “Circumstances”: C5567 C5599 substitute:C5794 C5795
Schedule 1, entry for Everolimus in the form Tablet 0.75 mg [Maximum Quantity: 240; Number of Repeats: 5]
omit from the column headed “Circumstances”: C5567 C5599 substitute:C5794 C5795
Schedule 1, entry for Everolimus in the form Tablet 1 mg [Maximum Quantity: 240; Number of Repeats: 5]
omit from the column headed “Circumstances”: C5567 C5599 substitute:C5794 C5795
Schedule 1, entry for Flucloxacillin in each of the forms: Powder for injection 500 mg (as sodium); and Powder for injection 1 g (as sodium)
omit from the column headed “Responsible Person” for the brand “Flubiclox” (all instances): EA substitute: JU
Schedule 1, entry for Fluconazole in each of the forms: Capsule 50 mg; Capsule 100 mg; and Capsule 200 mg
omit from the column headed “Circumstances” (all instances): C3613 C3614 C3615 C3616 C3617 C3618
substitute: C5667 C5668 C5728 C5752 C5790 C5811
Schedule 1, entry for Fluconazole in the form Powder for oral suspension 50 mg in 5 mL, 35 mL
omit from the column headed “Circumstances”: C3835 C3836 C3837 C3838 C3839 C3840
substitute: C5625 C5652 C5675 C5758 C5759 C5815
Schedule 1, entry for Fluconazole in each of the forms: Solution for I.V. infusion 100 mg in 50 mL; Solution for I.V. infusion 200 mg in
100 mL; and Solution for I.V. infusion 400 mg in 200 mL
omit from the column headed “Circumstances” (all instances): C3613 C3614 C3615 C3616 C3617 C3618
substitute: C5667 C5668 C5728 C5752 C5790 C5811
Schedule 1, entry for Flutamide
omit from the column headed “Circumstances”: C3674 substitute: C5816
Schedule 1, entry for Fondaparinux
omit from the column headed “Circumstances”: C2005 C2006 substitute: C5781 C5808
Schedule 1, entry for Fosinopril in each of the forms: Tablet containing fosinopril sodium 10 mg; and Tablet containing fosinopril sodium 20 mg
omit:
| GenRx Fosinopril | GX | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg
omit:
| APO‑Fosinopril HCTZ 10/12.5 | TX | MP NP | C4389 | 30 | 5 | 30 |
Schedule 1, entry for Glycerol
substitute:
| Glycerol | Suppositories 700 mg, 12 | Rectal | Petrus Pharmaceuticals Pty Ltd | PP | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 3 | 0 | 1 |
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 3 | 3 | 1 | |||||
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 3 | 5 | 1 | |||||
| MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | ||||
| Suppositories 1.4 g, 12 | Rectal | Petrus Pharmaceuticals Pty Ltd | PP | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 3 | 0 | 1 | |
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 3 | 3 | 1 | |||||
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 3 | 5 | 1 | |||||
| MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | ||||
| Suppositories 2.8 g, 12 | Rectal | Petrus Pharmaceuticals Pty Ltd | PP | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 3 | 0 | 1 | |
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 3 | 3 | 1 | |||||
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 3 | 5 | 1 | |||||
| MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) |
Schedule 1, entry for Granisetron in the form Concentrated injection 3 mg (as hydrochloride) in 3 mL
substitute:
| Granisetron | Tablet 2 mg (as hydrochloride) | Oral | Kytril | RO | MP NP | C4102 C4118 | P4118 | 2 | 0 | 1 |
| MP | C4139 | 2 | 0 | 1 | C(100) | |||||
| MP NP | C4102 C4118 | P4102 | 5 | 1 | 5 | |||||
| Concentrated injection 3 mg (as hydrochloride) in 3 mL | Injection | a | GRANISETRON APOTEX | TX | MP NP | C4077 C4092 | 1 | 0 | 1 | |
| MP | C4139 | 1 | 0 | 1 | C(100) | |||||
| a | Granisetron-AFT | AE | MP NP | C4077 C4092 | 1 | 0 | 1 | |||
| MP | C4139 | 1 | 0 | 1 | C(100) | |||||
| a | Granisetron Kabi | PK | MP NP | C4077 C4092 | 1 | 0 | 1 | |||
| MP | C4139 | 1 | 0 | 1 | C(100) | |||||
| a | Kytril | RO | MP NP | C4077 C4092 | 1 | 0 | 1 | |||
| MP | C4139 | 1 | 0 | 1 | C(100) |
Schedule 1, entry for Hyoscine in the form Injection containing hyoscine butylbromide 20 mg in 1 mL [Maximum Quantity: 30;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C3638 C3639 substitute: C5673 C5792
(b)omit from the column headed “Purposes”: P3639 substitute: P5673
Schedule 1, entry for Hyoscine in the form Injection containing hyoscine butylbromide 20 mg in 1 mL [Maximum Quantity: 30;
Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C3638 C3639 substitute: C5673 C5792
(b)omit from the column headed “Purposes”: P3638 substitute: P5792
Schedule 1, entry for Idarubicin in each of the forms: Capsule containing idarubicin hydrochloride 5 mg; and Capsule containing idarubicin hydrochloride 10 mg
omit from the column headed “Circumstances”: C1006 substitute: C5812
Schedule 1, entry for Indacaterol with glycopyrronium
omit from the column headed “Circumstances”: C4655 substitute: C5763
Schedule 1, entry for Infliximab
substitute:
| Infliximab | Powder for I.V. infusion 100 mg | Injection | a | Inflectra | HH | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
| MP | C4524 C4535 | P4535 | 1 | 1 | 1 | D(100) | ||||||
| MP | C4524 C4535 | P4524 | 5 | 1 | 1 | D(100) | ||||||
| a | Remicade | JC | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) | |||
| MP | C4524 C4535 | P4535 | 1 | 1 | 1 | D(100) | ||||||
| MP | C4524 C4535 | P4524 | 5 | 1 | 1 | D(100) |
Schedule 1, entry for Isotretinoin in each of the forms: Capsule 10 mg; Capsule 20 mg; and Capsule 40 mg
omit from the column headed “Responsible Person” for the brand “Oratane”: GN substitute: AG
Schedule 1, entry for Itraconazole
omit from the column headed “Circumstances”: C3607 C3608 C3609 C3610 C3612 C3613 C3614
substitute: C5698 C5699 C5700 C5728 C5760 C5790 C5793
Schedule 1, entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating) [Maximum Quantity: 28; Number of Repeats: 1]
(a)omit from the column headed “Circumstances” (all instances): C1177 C1337 C1533 substitute: C5682 C5741 C5802
(b)omit from the column headed “Purposes” (all instances): P1177 substitute: P5802
Schedule 1, entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating) [Maximum Quantity: 28; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances): C1177 C1337 C1533 substitute: C5682 C5741 C5802
(b)omit from the column headed “Purposes” (all instances): P1337 P1533 substitute: P5682 P5741
Schedule 1, entry for Lansoprazole in the form Capsule 30 mg [Maximum Quantity: 28; Number of Repeats: 1]
(a)omit from the column headed “Circumstances” (all instances): C1177 C1337 C1533 substitute: C5682 C5741 C5802
(b)omit from the column headed “Purposes” (all instances): P1177 substitute: P5802
Schedule 1, entry for Lansoprazole in the form Capsule 30 mg [Maximum Quantity: 28; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances): C1177 C1337 C1533 substitute: C5682 C5741 C5802
(b)omit from the column headed “Purposes” (all instances): P1337 P1533 substitute: P5682 P5741
Schedule 1, entry for Lansoprazole in each of the forms: Tablet 15 mg (orally disintegrating); and Capsule 15 mg
omit from the column headed “Circumstances”: C1337 C1533 substitute: C5444 C5512
Schedule 1, entry for Leflunomide in the form Tablet 10 mg
(a)omit from the column headed “Circumstances” for the brand “APO-Leflunomide”: C2644 substitute: C5681
(b)omit from the column headed “Circumstances” for the brands “Arabloc” and “Arava”: C2644 C2682 substitute: C5681 C5766
(c)substitute: C5681
(d)omit from the column headed “Circumstances” for the brand “Leflunomide Sandoz”: C2644 C2682 substitute: C5681 C5766
(e)omit from the column headed “Circumstances” for the brand “Lunava 10”: C2644 substitute: C5681
Schedule 1, entry for Leflunomide in the form Tablet 20 mg
(a)omit from the column headed “Circumstances” for the brand “APO-Leflunomide”: C2644 substitute: C5681
(b)omit from the column headed “Circumstances” for the brands “Arabloc” and “Arava”: C2644 C2682 substitute: C5681 C5766
(c)omit from the column headed “Circumstances” for the brands “Leflunomide AN”, “Leflunomide-GA” and “Leflunomide GH”: C2644
substitute: C5681
(d)omit from the column headed “Circumstances” for the brand “Leflunomide Sandoz”: C2644 C2682 substitute: C5681 C5766
(e)omit from the column headed “Circumstances” for the brand “Lunava 20”: C2644 substitute: C5681
Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Blooms the Chemist Lercanidipine | IB | MP NP | 28 | 5 | 28 |
Schedule 1, entry for Leuprorelin in each of the forms: I.M. injection (modified release), powder for injection containing leuprorelin acetate 7.5 mg with diluent in pre-filled dual-chamber syringe; Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 7.5 mg, injection set; I.M. injection (modified release), powder for injection containing leuprorelin acetate 22.5 mg with diluent in pre‑filled dual‑chamber syringe; Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 22.5 mg, injection set; and I.M. injection (modified release), powder for injection containing leuprorelin acetate 30 mg with diluent in pre‑filled dual‑chamber syringe
omit from the column headed “Circumstances”: C3229 substitute: C5646
Schedule 1, entry for Leuprorelin in the form I.M. injection (3 month modified release), powder for injection containing leuprorelin acetate 30 mg with diluent in pre-filled dual-chamber syringe
omit from the column headed “Circumstances”: C4884 substitute: C5627 C5706
Schedule 1, entry for Leuprorelin in each of the forms: Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 30 mg, injection set; and Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 45 mg, injection set
omit from the column headed “Circumstances”: C3229 substitute: C5646
Schedule 1, entry for Mannitol
omit from the column headed “Circumstances”: C4293 C4294 C4299 C4303 substitute: C5658 C5799
Schedule 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 500 mg
omit from the column headed “Circumstances”: C1543 substitute: C5731
Schedule 1, entry for Medroxyprogesterone in each of the forms: Tablet containing medroxyprogesterone acetate 100 mg; Tablet containing medroxyprogesterone acetate 200 mg; and Tablet containing medroxyprogesterone acetate 250 mg
omit from the column headed “Circumstances”: C1088 C1542 substitute: C5649 C5791
Schedule 1, entry for Methotrexate in the form Tablet 10 mg [Maximum Quantity: 50; Number of Repeats: 2]
omit from the column headed “Purposes”: P2884 substitute: P5648
Schedule 1, entry for Methylnaltrexone
substitute:
| Methylnaltrexone | Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL | Injection | Relistor | LM | MP NP | C5670 C5671 | P5670 | 3 | 0 | 1 |
| MP NP | C5670 C5671 | P5671 | 7 | 0 | 7 |
Schedule 1, entry for Metronidazole in the form Tablet 400 mg [Maximum Quantity: 21; Number of Repeats: 0]
(a)omit from the column headed “Circumstances” (all instances): C1416 C4932 substitute: C5701 C5702
(b)omit from the column headed “Purposes” (all instances): P1416 substitute: P5701
Schedule 1, entry for Metronidazole in the form Tablet 400 mg [Maximum Quantity: 21; Number of Repeats: 1]
(a)omit from the column headed “Circumstances” (all instances): C1416 C4932 substitute: C5701 C5702
(b)omit from the column headed “Purposes” (all instances): P4932 substitute: P5702
Schedule 1, entry for Moclobemide in the form Tablet 150 mg
(a)omit:
| Chem mart Moclobemide | CH | MP NP | C1211 | 60 | 5 | 60 |
(b)omit:
| Terry White Chemists Moclobemide | TW | MP NP | C1211 | 60 | 5 | 60 |
Schedule 1, entry for Moclobemide in the form Tablet 300 mg
(a)omit:
| Chem mart Moclobemide | CH | MP NP | C1211 | 60 | 5 | 60 |
(b)omit:
| Terry White Chemists Moclobemide | TW | MP NP | C1211 | 60 | 5 | 60 |
Schedule 1, entry for Mometasone in the form Lotion containing mometasone furoate 1 mg per g, 30 mL
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Momasone | QA | MP NP | C1422 | 1 | 0 | 1 |
Schedule 1, entry for Mycophenolic acid in the form Capsule containing mycophenolate mofetil 250 mg [Maximum Quantity: 600; Number of Repeats: 5]
(a)omit from the column headed “Purposes” (all instances): P5580 P5588
(b)insert in numerical order: P5626 P5653
(c)omit from the column headed “Maximum Quantity” (all instances): CN5580 CN5588
(d)insert in numerical order: CN5626 CN5653
(e)omit from the column headed “Number of Repeats” (all instances): CN5580 CN5588
(f)insert in numerical order: CN5626 CN5653
Schedule 1, entry for Mycophenolic acid in each of the forms: Tablet containing mycophenolate mofetil 500 mg; and Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL
(a)omit from the column headed “Purposes” (all instances): P5567 P5599 substitute: P5794 P5795
(b)omit from the column headed “Maximum Quantity” (all instances): CN5567 CN5599
(c)insert in numerical order: CN5794 CN5795
(d)omit from the column headed “Number of Repeats” (all instances): CN5567 CN5599
(e)insert in numerical order: CN5794 CN5795
Schedule 1, entry for Nilutamide
omit from the column headed “Circumstances”: C3300 C3675 substitute: C5647 C5785
Schedule 1, entry for Nitrazepam in the form Tablet 5 mg [Maximum Quantity: 50; Number of Repeats: 0]
(a)omit from the column headed “Purposes” (twice occurring): P3654 substitute: P5610
(b)omit from the column headed “Maximum Quantity” (twice occurring): CN3654 substitute: CN5610
Schedule 1, entry for Nitrazepam in the form Tablet 5 mg [Maximum Quantity: 50; Number of Repeats: 3]
(a)omit from the column headed “Purposes” (twice occurring): P3653 substitute: P5662
(b)omit from the column headed “Maximum Quantity” (twice occurring): CN3653 substitute: CN5662
(c)omit from the column headed “Number of Repeats” (twice occurring): CN3653 substitute: CN5662
Schedule 1, entry for Nitrazepam in the form Tablet 5 mg [Maximum Quantity: 50; Number of Repeats: 5]
(a)omit from the column headed “Purposes” (twice occurring): P1123 P1126 P1216 P1235
substitute: P5661 P5684 P5770 P5771
(b)omit from the column headed “Maximum Quantity” (twice occurring): CN1123 CN1126 CN1216 CN1235
substitute: CN5661 CN5684 CN5770 CN5771
(c)omit from the column headed “Number of Repeats” (twice occurring): CN1123 CN1126 CN1216 CN1235
substitute: CN5661 CN5684 CN5770 CN5771
Schedule 1, entry for Norfloxacin
omit from the column headed “Circumstances” (all instances): C1002 C1070 substitute: C5744 C5806
Schedule 1, entry for Octreotide in each of the forms: Injection (modified release) 10 mg (as acetate), vial and diluent syringe; Injection (modified release) 20 mg (as acetate), vial and diluent syringe; and Injection (modified release) 30 mg (as acetate), vial and diluent syringe
omit from the column headed “Circumstances”: C4560 C4561 C4563 C4564 C4568 C4571
substitute: C5628 C5654 C5678 C5707 C5737 C5738
Schedule 1, entry for Omeprazole in the form Tablet 10 mg (as magnesium)
omit from the column headed “Circumstances”: C1337 C1476 C1533 substitute: C5444 C5512 C5529
Schedule 1, entry for Ondansetron
substitute:
| Ondansetron | I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL | Injection | a | Ondansetron Alphapharm | AF | MP NP | C4077 C4092 | 1 | 0 | 1 |
| MP | C5749 | 1 | 0 | 1 | C(100) | |||||
| a | Ondansetron Kabi | PK | MP NP | C4077 C4092 | 1 | 0 | 1 | |||
| MP | C5749 | 1 | 0 | 1 | C(100) | |||||
| a | Ondansetron-Claris | AE | MP NP | C4077 C4092 | 1 | 0 | 1 | |||
| MP | C5749 | 1 | 0 | 1 | C(100) | |||||
| a | Onsetron | ZP | MP NP | C4077 C4092 | 1 | 0 | 1 | |||
| MP | C5749 | 1 | 0 | 1 | C(100) | |||||
| I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL | Injection | a | Ondansetron Alphapharm | AF | MP NP | C4077 C4092 | 1 | 0 | 1 | |
| MP | C5749 | 1 | 0 | 1 | C(100) | |||||
| a | Ondansetron Kabi | PK | MP NP | C4077 C4092 | 1 | 0 | 1 | |||
| MP | C5749 | 1 | 0 | 1 | C(100) | |||||
| a | Ondansetron-Claris | AE | MP NP | C4077 C4092 | 1 | 0 | 1 | |||
| MP | C5749 | 1 | 0 | 1 | C(100) | |||||
| a | Onsetron | ZP | MP NP | C4077 C4092 | 1 | 0 | 1 | |||
| MP | C5749 | 1 | 0 | 1 | C(100) | |||||
| Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL | Oral | Zofran syrup 50 mL | AS | MP NP | C4102 C5721 | P5721 | 1 | 0 | 1 | |
| MP | C5778 | 1 | 0 | 1 | C(100) | |||||
| MP NP | C4102 C5721 | P4102 | 1 | 1 | 1 | |||||
| Tablet (orally disintegrating) 4 mg | Oral | Ondansetron AN ODT | EA | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 | |
| MP | C5743 | 4 | 0 | 4 | C(100) | |||||
| Ondansetron ODT-DRLA | RZ | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 | |||
| MP | C5743 | 4 | 0 | 4 | C(100) | |||||
| Ondansetron SZ ODT | HX | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 | |||
| MP | C5743 | 4 | 0 | 4 | C(100) | |||||
| Onsetron ODT 4 | ED | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 | |||
| MP | C5743 | 4 | 0 | 4 | C(100) | |||||
| Ondansetron AN ODT | EA | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 | |||
| Ondansetron ODT-DRLA | RZ | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 | |||
| Ondansetron SZ ODT | HX | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 | |||
| Onsetron ODT 4 | ED | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 | |||
| Zilfojim ODT 4 | DO | MP NP | C5777 | 10 | 1 | 10 | ||||
| Tablet 4 mg (as hydrochloride dihydrate) | Oral | a | APO-Ondansetron | TX | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 |
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | Ondansetron AN | EA | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 | ||
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | Ondansetron SZ | HX | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 | ||
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | Ondansetron-DRLA | RZ | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 | ||
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | Ondaz | SZ | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 | ||
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | Onsetron 4 | ZP | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 | ||
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | Zofran | AS | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 | ||
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | APO-Ondansetron | TX | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| a | Ondansetron AN | EA | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| a | Ondansetron SZ | HX | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| a | Ondansetron-DRLA | RZ | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| a | Ondaz | SZ | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| a | Onsetron 4 | ZP | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| a | Zilfojim 4 | DO | MP NP | C4102 | 10 | 1 | 10 | |||
| a | Zofran | AS | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| Tablet (orally disintegrating) 8 mg | Oral | Ondansetron AN ODT | EA | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 | |
| MP | C5743 | 4 | 0 | 4 | C(100) | |||||
| Ondansetron ODT-DRLA | RZ | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 | |||
| MP | C5743 | 4 | 0 | 4 | C(100) | |||||
| Ondansetron SZ ODT | HX | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 | |||
| MP | C5743 | 4 | 0 | 4 | C(100) | |||||
| Onsetron ODT 8 | ED | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 | |||
| MP | C5743 | 4 | 0 | 4 | C(100) | |||||
| Ondansetron AN ODT | EA | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 | |||
| Ondansetron ODT-DRLA | RZ | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 | |||
| Ondansetron SZ ODT | HX | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 | |||
| Onsetron ODT 8 | ED | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 | |||
| Zilfojim ODT 8 | DO | MP NP | C5777 | 10 | 1 | 10 | ||||
| Tablet 8 mg (as hydrochloride dihydrate) | Oral | a | APO-Ondansetron | TX | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 |
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | Ondansetron AN | EA | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 | ||
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | Ondansetron SZ | HX | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 | ||
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | Ondansetron-DRLA | RZ | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 | ||
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | Ondaz | SZ | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 | ||
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | Onsetron 8 | ZP | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 | ||
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | Zofran | AS | MP NP | C4102 C4118 | P4118 | 4 | 0 | 4 | ||
| MP | C5778 | 4 | 0 | 4 | C(100) | |||||
| a | APO-Ondansetron | TX | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| a | Ondansetron AN | EA | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| a | Ondansetron SZ | HX | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| a | Ondansetron-DRLA | RZ | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| a | Ondaz | SZ | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| a | Onsetron 8 | ZP | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| a | Zilfojim 8 | DO | MP NP | C4102 | 10 | 1 | 10 | |||
| a | Zofran | AS | MP NP | C4102 C4118 | P4102 | 10 | 1 | 10 | ||
| Wafer 4 mg | Oral | Ondaz Zydis | SZ | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 | |
| MP | C5743 | 4 | 0 | 4 | C(100) | |||||
| Zofran Zydis | AS | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 | |||
| MP | C5743 | 4 | 0 | 4 | C(100) | |||||
| Ondaz Zydis | SZ | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 | |||
| Zofran Zydis | AS | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 | |||
| Wafer 8 mg | Oral | Ondaz Zydis | SZ | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 | |
| MP | C5743 | 4 | 0 | 4 | C(100) | |||||
| Zofran Zydis | AS | MP NP | C5618 C5777 | P5618 | 4 | 0 | 4 | |||
| MP | C5743 | 4 | 0 | 4 | C(100) | |||||
| Ondaz Zydis | SZ | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 | |||
| Zofran Zydis | AS | MP NP | C5618 C5777 | P5777 | 10 | 1 | 10 |
Schedule 1, entry for Oxybutynin in the form Transdermal patches 36 mg, 8
omit from the column headed “Responsible Person”: GN substitute: AG
Schedule 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 30 mg in 5 mL; Solution concentrate for I.V. infusion 100 mg in 16.7 mL; Solution concentrate for I.V. infusion 150 mg in 25 mL; and Solution concentrate for I.V. infusion 300 mg
in 50 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Paclitaxel ACT | EF | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Palonosetron
substitute:
| Palonosetron | Injection 250 micrograms (as hydrochloride) in 5 mL | Injection | Aloxi | TS | MP NP | C5686 | 1 | 0 | 1 |
| MP | C5805 | 1 | 0 | 1 | C(100) |
Schedule 1, entry for Pancreatic Extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity [Maximum Quantity: 500; Number of Repeats: 21]
omit from the column headed “Purposes”: P3046 substitute: P5779
Schedule 1, entry for Pancreatic Extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity [Maximum Quantity: 200; Number of Repeats: 21]
omit from the column headed “Purposes”: P3046 substitute: P5779
Schedule 1, entry for Pancreatic Extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity [Maximum Quantity: 200; Number of Repeats: 21]
omit from the column headed “Purposes”: P3046 substitute: P5779
Schedule 1, entry for Pancreatic Extract in the form Granules (enteric coated) providing not less than 5,000 BP units of lipase activity per 100 mg, 20 g [Maximum Quantity: 3; Number of Repeats: 21]
omit from the column headed “Purposes”: P3046 substitute: P5779
Schedule 1, entry for Pancrelipase in the form Capsule (containing enteric coated microtablets) providing not less than 25,000 BP units of lipase activity [Maximum Quantity: 200; Number of Repeats: 21]
omit from the column headed “Purposes”: P3046 substitute: P5779
Schedule 1, entry for Paraffin in the form Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g
(a)omit:
| Duratears | AQ | MP NP AO | 2 | 5 | 1 |
(b)omit:
| Duratears | AQ | MP | P3035 | 2 | 11 | 1 |
(c)omit from the column headed “Purposes” for the brand “Poly Visc”: P3035 substitute: P5713
Schedule 1, entry for Phenoxymethylpenicillin in the form Tablet 250 mg phenoxymethylpenicillin (as potassium) [Maximum Quantity: 50; Number of Repeats: 5]
omit from the column headed “Purposes”: P1304 substitute: P5697
Schedule 1, entry for Phenoxymethylpenicillin in the form Capsule 250 mg phenoxymethylpenicillin (as potassium) [Maximum Quantity: 50; Number of Repeats: 5]
omit from the column headed “Purposes”: P1304 (all instances)substitute: P5697
Schedule 1, entry for Posaconazole in the form Oral suspension 40 mg per mL, 105 mL
omit from the column headed “Circumstances”: C3058 C3059 C3060 substitute: C5617 C5724 C5747
Schedule 1, entry for Praziquantel
omit from the column headed “Circumstances”: C3147 substitute: C5659
Schedule 1, entry for Quetiapine in each of the forms: Tablet 100 mg (as fumarate); Tablet 200 mg (as fumarate); Tablet 300 mg
(as fumarate); Tablet (modified release) 50 mg (as fumarate); Tablet (modified release) 150 mg (as fumarate); Tablet (modified release)
200 mg (as fumarate); Tablet (modified release) 300 mg (as fumarate); and Tablet (modified release) 400 mg (as fumarate)
omit from the column headed “Circumstances” (all instances): C1589 C2044 C2765 substitute: C4246 5611 C5639
Schedule 1, entry for Quinine
omit from the column headed “Circumstances”: C2142 substitute: C5633
Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)
omit from the column headed “Circumstances” (all instances): C1337 C1533 substitute: C5444 C5512
Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30;
Number of Repeats: 2]
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Rabeprazole SUN | RN | MP NP | C5444 C5445 C5512 | P5445 | 30 | 2 | 30 |
(c)omit from the column headed “Circumstances” (all instances): C1177 C1337 C1533 substitute: C5444 C5445 C5512
(d)omit from the column headed “Purposes” (all instances): P1177 substitute: P5445
Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30;
Number of Repeats: 5]
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Rabeprazole SUN | RN | MP NP | C5444 C5445 C5512 | P5444 P5512 | 30 | 5 | 30 |
(c)omit from the column headed “Circumstances” (all instances): C1177 C1337 C1533 substitute: C5444 C5445 C5512
(d)omit from the column headed “Purposes” (all instances): P1337 P1533 substitute: P5444 C5512
Schedule 1, entry for Reteplase
omit from the column headed “Circumstances”: C1480 substitute: C5810
Schedule 1, after entry for Rivastigmine in the form Transdermal patch 18 mg
insert in the columns in the order indicated:
| Transdermal patch 27 mg | Transdermal | Exelon Patch 15 | NV | MP NP | C4219 C4220 C4224 | 30 | 5 | 30 |
Schedule 1, entry for Rizatriptan
insert as first item in the columns in the order indicated:
| Tablet (orally disintegrating) 10 mg (as benzoate) | Oral | Rizatriptan AN ODT | EA | MP NP | C5708 | 4 | 5 | 2 |
Schedule 1, entry for Rizatriptan in the form Wafer 10 mg (as benzoate)
(a)omit from the column headed “Circumstances” for the brand “Maxalt”: C5141 substitute: C5708
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Rizatriptan Wafers-10mg | FR | MP NP | C5708 | 4 | 5 | 2 |
Schedule 1, entry for Saxagliptin in each of the forms: Tablet 2.5 mg (as hydrochloride); and Tablet 5 mg (as hydrochloride)
omit from the column headed “Circumstances”: C4520 substitute: C5623 C5679
Schedule 1, entry for Saxagliptin with metformin in each of the forms: Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride; Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with
500 mg metformin hydrochloride; and Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride
omit from the column headed “Circumstances”: C4423 C4451 substitute: C5705 C5761 C5762
Schedule 1, entry for Sirolimus in each of the forms: Tablet 0.5 mg; Tablet 1 mg; Tablet 2 mg; and Oral solution 1 mg per mL, 60 mL
(a)omit from the column headed “Purposes”: P5567 P5599 substitute: P5794 P5795
(b)omit from each of the columns headed “Maximum Quantity” and “Number of Repeats”: CN5567 CN5599 substitute: CN5794 CN5795
Schedule 1, entry for Sitagliptin in each of the forms: Tablet 25 mg (as phosphate monohydrate); Tablet 50 mg (as phosphate monohydrate); and Tablet 100 mg (as phosphate monohydrate)
omit from the column headed “Circumstances”: C4519 substitute: C5655 C5679
Schedule 1, entry for Sitagliptin with metformin in each of the forms: Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 500 mg metformin hydrochloride; Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 850 mg metformin hydrochloride; Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride; Tablet (modified release) containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride; and Tablet (modified release) containing 100 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride
omit from the column headed “Circumstances”: C4309 C4423 substitute: C5705 C5709 C5761
Schedule 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Omnitrope Surepal 5 | SZ | MP | C5150 C5151 C5152 C5153 C5156 C5157 C5158 C5165 C5166 C5167 C5198 C5199 C5201 C5202 C5211 C5235 C5236 C5237 C5242 C5247 C5285 C5286 C5287 C5305 C5306 C5310 C5318 C5319 C5320 C5346 C5348 C5352 C5353 C5354 C5355 C5378 C5379 C5380 C5419 C5420 C5432 C5433 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Omnitrope Surepal 10 | SZ | MP | C5150 C5151 C5152 C5153 C5156 C5157 C5158 C5165 C5166 C5167 C5198 C5199 C5201 C5202 C5211 C5235 C5236 C5237 C5242 C5247 C5285 C5286 C5287 C5305 C5306 C5310 C5318 C5319 C5320 C5346 C5348 C5352 C5353 C5354 C5355 C5378 C5379 C5380 C5419 C5420 C5432 C5433 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
substitute:
| Sorbitol with sodium citrate and sodium lauryl sulfoacetate | Enemas 3.125 g‑450 mg‑45 mg in 5 mL, 12 | Rectal | a | Micolette | AE | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 2 | 0 | 1 |
| a | Microlax | JT | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 2 | 0 | 1 | |||
| a | Micolette | AE | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 2 | 2 | 1 | |||
| a | Microlax | JT | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 2 | 2 | 1 | |||
| a | Micolette | AE | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 2 | 3 | 1 | |||
| a | Microlax | JT | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 2 | 3 | 1 | |||
| a | Micolette | AE | MP | See Note 2 | 4 | 0 | 12 | C(100) | |||
| a | Microlax | JT | MP | See Note 2 | 4 | 0 | 12 | C(100) |
Schedule 1, entry for Sotalol in the form Tablet containing sotalol hydrochloride 80 mg
omit from the column headed “Circumstances” (all instances): C1350 substitute: C5664
Schedule 1, entry for Sotalol in the form Tablet containing sotalol hydrochloride 160 mg
(a)omit:
| Chem mart Sotalol | CH | MP NP | C1350 | 60 | 5 | 60 |
(b)omit:
| GenRx Sotalol | GX | MP NP | C1350 | 60 | 5 | 60 |
(c)omit:
| Terry White Chemists Sotalol | TW | MP NP | C1350 | 60 | 5 | 60 |
(d)omit from the column headed “Circumstances” (all instances): C1350 substitute: C5664
Schedule 1, entry for Sterculia with Frangula Bark
substitute:
| Sterculia with frangula bark | Granules 620 mg‑80 mg per g, 500 g | Oral | Normacol Plus | NE | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 1 | 0 | 1 |
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 1 | 1 | 1 | |||||
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 1 | 3 | 1 | |||||
| MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) |
Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [Maximum Quantity: 4; Number of Repeats: 5; Pack Quantity: 4]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Imigran | LN | MP NP | C5259 | 4 | 5 | 4 |
Schedule 1, entry for Tamoxifen in the form Tablet 10 mg (as citrate)
omit from the column headed “Circumstances”: C1749 substitute: C5730
Schedule 1, entry for Tamoxifen in the form Tablet 20 mg (as citrate)
omit from the column headed “Circumstances” (all instances): C1749 substitute: C5621
Schedule 1, entry for Temazepam in the form Tablet 10 mg [Maximum Quantity: 50; Number of Repeats: 0]
(a)omit from the column headed “Purposes” (all instances): P3654 substitute: P5610
(b)omit from the column headed “Maximum Quantity” (all instances): CN3654 substitute: CN5610
Schedule 1, entry for Temazepam in the form Tablet 10 mg [Maximum Quantity: 50; Number of Repeats: 3]
(a)omit from the column headed “Purposes” (all instances): P3653 substitute: P5662
(b)omit from the column headed “Maximum Quantity” (all instances): CN3653 substitute: CN5662
(c)omit from the column headed “Number of Repeats” (all instances): CN3653 substitute: CN5662
Schedule 1, entry for Temazepam in the form Tablet 10 mg [Maximum Quantity: 50; Number of Repeats: 5]
(a)omit from the column headed “Purposes” (all instances): P1123 P1126 P1216 substitute: P5661 P5684 P5770
(b)omit from the column headed “Maximum Quantity” (all instances): CN1123 CN1126 CN1216 substitute: CN5661 CN5684 CN5770
(c)omit from the column headed “Number of Repeats” (all instances): CN1123 CN1126 CN1216 substitute: CN5661 CN5684 CN5770
Schedule 1, entry for Tenecteplase in each of the forms: Powder for injection 40 mg with solvent; and Powder for injection 50 mg
with solvent
omit from the column headed “Circumstances”: C1481 substitute: C5783
Schedule 1, entry for Testosterone in each of the forms: Transdermal patches 12.2 mg, 60; and Transdermal patches 24.3 mg, 30
omit from the column headed “Responsible Person”: GN substitute: AG
Schedule 1, entry for Ticagrelor
omit from the column headed “Circumstances”: C3879 substitute: C5746
Schedule 1, after entry for Tiotropium in the form Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation
(60 doses)
insert:
| Tiotropium with olodaterol | Solution for oral inhalation containing tiotropium 2.5 micrograms (as bromide monohydrate) with olodaterol 2.5 micrograms (hydrochloride) per dose, 60 doses | Inhalation by mouth | Spiolto Respimat | BY | MP NP | C5763 | 1 | 5 | 1 |
Schedule 1, entry for Tipranavir
omit from the column headed “Circumstances”: C4981 substitute: C5764
Schedule 1, entry for Tirofiban
(a)omit from the column headed “Responsible Person” for the brand “Tirofiban AC”: GN substitute: JO
(b)omit from the column headed “Circumstances” (twice occurring): C1275 C1729 C1730 substitute: C5691 C5782 C5809
Schedule 1, entry for Triglycerides, long chain with glucose polymer in each of the forms: Oral liquid 250 mL, 18 (ProZero); and
Oral liquid 1 L, 6 (ProZero)
omit from the column headed “Circumstances”: C1276 substitute: C4438
Schedule 1, entry for Triglycerides, medium chain in each of the forms: Oil 500 mL (MCT Oil); and Oral emulsion 250 mL (Liquigen)
omit from the column headed “Circumstances”: C1068 C1511 C1513 C1670 C1671 C1672
substitute: C4379 C4393 C5616 C5690 C5723 C5807
Schedule 1, entry for Triglycerides—medium chain, formula in the form Sachets containing oral powder 16 g, 30 (MCT Pro-Cal)
omit from the column headed “Circumstances”: C1068 C1511 C1513 C1670 C1671 substitute: C5644 C5645 C5693 C5726 C5784
Schedule 1, entry for Triglycerides, medium chain and long chain with glucose polymer
omit from the column headed “Circumstances”: C1276 substitute: C4438
Schedule 1, entry for Triptorelin in each of the forms: Powder for I.M. injection (prolonged release) 3.75 mg (as embonate) with solvent, syringe and needles; Powder for I.M. injection (prolonged release) 11.25 mg (as embonate) with solvent, syringe and needles; and
Powder for I.M. injection (prolonged release) 22.5 mg (as embonate) with solvent, syringe and needles
omit from the column headed “Circumstances”: C3229 substitute: C5646
Schedule 1, entry for Tropisetron
substitute:
| Tropisetron | I.V. injection 5 mg (as hydrochloride) in 5 mL | Injection | Tropisetron‑AFT | AE | MP NP | C4077 | 1 | 0 | 1 |
| MP | C5749 | 1 | 0 | 1 | C100 |
Schedule 1, entry for Umeclidinium with vilanterol
omit from the column headed “Circumstances”: C4655 substitute: C5763
Schedule 1, entry for Ursodeoxycholic Acid
omit from the column headed “Circumstances” (twice occurring): C1700 substitute: C5757
Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 20; Number of Repeats: 0]
(a)omit:
| Chem mart Valaciclovir | CH | MP NP | C3622 C3623 C3624 C3631 C3632 | P3632 | 20 | 0 | 10 |
(b)omit:
| Terry White Chemists Valaciclovir | TW | MP NP | C3622 C3623 C3624 C3631 C3632 | P3632 | 20 | 0 | 10 |
Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” for the brand “Chem mart Valaciclovir”: C3632
(b)omit from the column headed “Circumstances” for the brand “Terry White Chemists Valaciclovir”: C3632
Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 0]
(a)omit from the column headed “Circumstances” for the brand “Chem mart Valaciclovir”: C3632
(b)omit from the column headed “Circumstances” for the brand “Terry White Chemists Valaciclovir”: C3632
Schedule 1, entry for Vancomycin in each of the forms: Capsule 125 mg (125,000 I.U.) (as hydrochloride); and Capsule 250 mg (250,000 I.U.) (as hydrochloride)
omit from the column headed “Circumstances”: C1701 C1702 substitute: C5636 C5660
Schedule 1, entry for Vancomycin in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) [Maximum Quantity: 2;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances” [Authorised Prescriber MP] (all instances): C1091 C1302 C1464
substitute: C5716 C5717 C5769
(b)omit from the column headed “Purposes” (all instances): P1302 substitute: P5717
(c)omit from the column headed “Circumstances” [Authorised Prescriber PDP]: C1302 substitute: C5801
Schedule 1, entry for Vancomycin in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) [Maximum Quantity: 5;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances” (all instances): C1091 C1302 C1464 substitute: C5716 C5717 C5769
(b)omit from the column headed “Purposes” (all instances): P1091 P1464 substitute: P5716 P5769
Schedule 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) [Maximum Quantity: 1;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances” [Authorised Prescriber MP] (all instances): C1091 C1302 C1464
substitute: C5716 C5717 C5769
(b)omit from the column headed “Purposes” (all instances): P1302 substitute: P5717
(c)omit from the column headed “Circumstances” [Authorised Prescriber PDP]: C1302 substitute: C5801
Schedule 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) [Maximum Quantity: 3;
Number of Repeats: 0]
(a)omit from the column headed “Circumstances” (all instances): C1091 C1302 C1464 substitute: C5716 C5717 C5769
(b)omit from the column headed “Purposes” (all instances): P1091 P1464 substitute: P5716 P5769
Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 37.5 mg (as hydrochloride); Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)
omit from the column headed “Circumstances”: C1211 substitute: C5650
Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C4665 C4682
(b)omit: C4748
(c)insert in numerical order: C5692 C5725 C5748
Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4665 C4682
(b)omit: C4748
(c)insert in numerical order: C5692 C5725 C5748
(d)omit from the column headed “Purposes”: P4665 P4682
(e)omit: P4748
(f)insert in numerical order: P5692 P5725 P5748
Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C4665 C4682
(b)omit: C4748
(c)insert in numerical order: C5692 C5725 C5748
Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4665 C4682
(b)omit: C4748
(c)insert in numerical order: C5692 C5725 C5748
(d)omit from the column headed “Purposes”: P4665 P4682
(e)omit: P4748
(f)insert in numerical order: P5692 P5725 P5748
Schedule 1, entry for Voriconazole in the form Powder for oral suspension 40 mg per mL, 70 mL
omit from the column headed “Circumstances”: C4699 C4722 C4723 C4749 substitute: C5624 C5734 C5813 C5814
Schedule 1, entry for Ziprasidone in each of the forms: Capsule 20 mg (as hydrochloride); Capsule 40 mg (as hydrochloride);
Capsule 60 mg (as hydrochloride); and Capsule 80 mg (as hydrochloride)
omit from the column headed “Circumstances” (all instances): C1589 C3084 substitute: C4246 C5742
Schedule 1, entry for Zoledronic acid
substitute:
| Zoledronic acid | Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL | Injection | APO-Zoledronic Acid | TX | MP | C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736 | 1 | 11 | 1 | PB(100) |
| DBL Zoledronic Acid | HH | MP | C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736 | 1 | 11 | 1 | PB(100) | |||
| Zometa | NV | MP | C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736 | 1 | 11 | 1 | PB(100) | |||
| Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL | Injection | DBL Zoledronic Acid | HH | MP | C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736 | 1 | 11 | 1 | PB(100) | |
| Zometa | NV | MP | C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736 | 1 | 11 | 1 | PB(100) | |||
| Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL | Injection | a | Aclasta | NV | MP | C5656 C5710 C5765 C5796 | 1 | 0 | 1 | |
| a | Osteovan | SZ | MP | C5656 C5710 C5765 C5796 | 1 | 0 | 1 | |||
| a | Ostira | HH | MP | C5656 C5710 C5765 C5796 | 1 | 0 | 1 | |||
| a | Zoledasta | TX | MP | C5656 C5710 C5765 C5796 | 1 | 0 | 1 |
Schedule 3, after details relevant to Responsible Person code JN
insert:
| JO | Juno Pharmaceuticals Pty Ltd | 55 156 303 650 |
Schedule 3, after details relevant to Responsible Person code JT
insert:
| JU | Juno Pharmaceuticals Pty Ltd | 55 156 303 650 |
Schedule 3, after details relevant to Responsible Person code RI
insert:
| RN | Ranbaxy Australia Pty Limited | 17 110 871 826 |
Schedule 4, Part 1, entry for Acitretin
substitute:
| Acitretin | C5727 | Severe disorders of keratinisation | Compliance with Authority Required procedures - Streamlined Authority Code 5727 |
| C5789 | Severe intractable psoriasis | Compliance with Authority Required procedures - Streamlined Authority Code 5789 |
Schedule 4, Part 1, after entry for Aclidinium
insert:
| Aclidinium with eformoterol | C5763 | Chronic obstructive pulmonary disease (COPD) Patient must have been stabilised on a combination of a long acting muscarinic antagonist and long acting beta-2 agonist. | Compliance with Authority Required procedures - Streamlined Authority Code 5763 |
Schedule 4, Part 1, entry for Albendazole
substitute:
| Albendazole | C5607 | Hydatid disease The treatment must be in conjunction with surgery; OR | Compliance with Authority Required procedures - Streamlined Authority Code 5607 |
| C5680 | P5680 | Tapeworm infestation | Compliance with Authority Required procedures - Streamlined Authority Code 5680 |
| C5712 | P5712 | Strongyloidiasis | Compliance with Authority Required procedures - Streamlined Authority Code 5712 |
| C5797 | P5797 | Hookworm infestation | Compliance with Authority Required procedures - Streamlined Authority Code 5797 |
| C5817 | P5817 | Whipworm infestation Patient must be an Aboriginal or a Torres Strait Islander person. | Compliance with Authority Required procedures - Streamlined Authority Code 5817 |
Schedule 4, Part 1, entry for Alprazolam
substitute:
| Alprazolam | C5608 | Panic disorder The treatment must be for use when other treatments have failed; OR | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Amino acid formula without phenylalanine
substitute:
| Amino acid formula without phenylalanine | C4295 | Phenylketonuria |
Schedule 4, Part 1, entry for Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine
substitute:
| Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine | C4295 | Phenylketonuria |
Schedule 4, Part 1, entry for Amiodarone
substitute:
| Amiodarone | C5665 | Severe cardiac arrhythmias |
Schedule 4, Part 1, entry for Amisulpride
substitute:
| Amisulpride | C4246 | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 4246 |
Schedule 4, Part 1, entry for Amlodipine with atorvastatin
substitute:
| Amlodipine with atorvastatin | C5619 | Hypertension Patient must meet the criteria set out in the General Statement for Lipid-Lowering Drugs; AND |
| C5694 | Angina Patient must meet the criteria set out in the General Statement for Lipid-Lowering Drugs; AND | |
| C5750 | Hypertension Patient must meet the criteria set out in the General Statement for Lipid-Lowering Drugs; AND | |
| C5751 | Angina Patient must meet the criteria set out in the General Statement for Lipid-Lowering Drugs; AND | |
| C5787 | Angina Patient must meet the criteria set out in the General Statement for Lipid-Lowering Drugs; AND | |
| C5788 | Hypertension Patient must meet the criteria set out in the General Statement for Lipid-Lowering Drugs; AND |
Schedule 4, Part 1, entry for Artemether with lumefantrine
substitute:
| Artemether with lumefantrine | C5632 | Confirmed or suspected Plasmodium falciparum malaria Patient must be unable to swallow a solid dosage form of artemether with lumefantrine. | Compliance with Authority Required procedures |
| C5767 | Confirmed or suspected Plasmodium falciparum malaria | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Asenapine
substitute:
| Asenapine | C4246 | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 4246 |
| C5719 | Bipolar I disorder The treatment must be maintenance therapy; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5719 | |
| C5773 | Acute mania or mixed episodes The condition must be associated with bipolar I disorder; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5773 |
Schedule 4, Part 1, entry for Atorvastatin
substitute:
| Atorvastatin | C4238 | P4238 | For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs Patient must be receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements. |
| C4263 | P4263 | For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs |
substitute:
| Quinine | C5633 | Malaria | Compliance with Authority Required procedures - Streamlined Authority Code 5633 |
Schedule 4, Part 1, entry for Rabeprazole
substitute:
| Rabeprazole | C5444 | P5444 | Gastro-oesophageal reflux disease |
| C5445 | P5445 | Peptic ulcer Initial treatment | |
| C5512 | P5512 | Scleroderma oesophagus |
Schedule 4, Part 1, entry for Reteplase
substitute:
| Reteplase | C5810 | Acute myocardial infarction The treatment must be administered within 6 hours of the onset of attack. |
Schedule 4, Part 1, entry for Rizatriptan
substitute:
| Rizatriptan | C5708 | Migraine attack The condition must have usually failed to respond to analgesics in the past. |
Schedule 4, Part 1, entry for Saxagliptin
substitute:
| Saxagliptin | C5623 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR | Compliance with Authority Required procedures - Streamlined Authority Code 5623 |
| C5679 | Diabetes mellitus type 2 The treatment must be in combination with metformin; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5679 |
Schedule 4, Part 1, entry for Saxagliptin with metformin
substitute:
| Saxagliptin with metformin | C5705 | Diabetes mellitus type 2 The treatment must be in combination with a sulfonylurea; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5705 |
| C5761 | Diabetes mellitus type 2 Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR | Compliance with Authority Required procedures - Streamlined Authority Code 5761 | |
| C5762 | Diabetes mellitus type 2 Continuing Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and saxagliptin. | Compliance with Authority Required procedures - Streamlined Authority Code 5762 |
Schedule 4, Part 1, entry for Sirolimus
substitute:
| Sirolimus | P5794 | CN5794 | Management of renal allograft rejection Management (initiation, stabilisation and review of therapy) Patient must be receiving this drug for prophylaxis of renal allograft rejection, AND The treatment must be under the supervision and direction of a transplant unit. | Compliance with Written or Telephone Authority Required procedures |
| P5795 | CN5795 | Management of renal allograft rejection Management (initiation, stabilisation and review of therapy) Patient must be receiving this drug for prophylaxis of renal allograft rejection, AND The treatment must be under the supervision and direction of a transplant unit. | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5795 |
Schedule 4, Part 1, entry for Sitagliptin
substitute:
| Sitagliptin | C5655 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR | Compliance with Authority Required procedures - Streamlined Authority Code 5655 |
| C5679 | Diabetes mellitus type 2 The treatment must be in combination with metformin; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5679 |
Schedule 4, Part 1, entry for Sitagliptin with metformin
substitute:
| Sitagliptin with metformin | C5705 | Diabetes mellitus type 2 The treatment must be in combination with a sulfonylurea; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5705 |
| C5709 | Diabetes mellitus type 2 Continuing Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and sitagliptin. | Compliance with Authority Required procedures - Streamlined Authority Code 5709 | |
| C5761 | Diabetes mellitus type 2 Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR | Compliance with Authority Required procedures - Streamlined Authority Code 5761 |
Schedule 4, Part 1, entry for Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
substitute:
| Sorbitol with sodium citrate and sodium lauryl sulfoacetate | C5613 | P5613 | Constipation Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult. |
| C5640 | P5640 | Constipation Patient must be paraplegic or quadriplegic or have severe neurogenic impairment of bowel function. | |
| C5641 | P5641 | Constipation Continuing treatment Patient must be receiving palliative care. | Compliance with Authority Required procedures - Streamlined Authority Code 5641 |
| C5685 | P5685 | Anorectal congenital abnormalities | |
| C5720 | P5720 | Constipation Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility. | |
| C5774 | P5774 | Constipation Initial treatment, for up to 4 months Patient must be receiving palliative care. | Compliance with Authority Required procedures - Streamlined Authority Code 5774 |
| C5775 | P5775 | Constipation Patient must be receiving palliative care. | |
| C5776 | P5776 | Terminal malignant neoplasia | |
| C5804 | P5804 | Megacolon |
Schedule 4, Part 1, entry for Sotalol
substitute:
| Sotalol | C5664 | Severe cardiac arrhythmias |
Schedule 4, Part 1, entry for Sterculia with Frangula Bark
substitute:
| Sterculia with frangula bark | C5613 | P5613 | Constipation Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult. |
| C5640 | P5640 | Constipation Patient must be paraplegic or quadriplegic or have severe neurogenic impairment of bowel function. | |
| C5641 | P5641 | Constipation Continuing treatment Patient must be receiving palliative care. | Compliance with Authority Required procedures - Streamlined Authority Code 5641 |
| C5685 | P5685 | Anorectal congenital abnormalities | |
| C5720 | P5720 | Constipation Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility. | |
| C5774 | P5774 | Constipation Initial treatment, for up to 4 months Patient must be receiving palliative care. | Compliance with Authority Required procedures - Streamlined Authority Code 5774 |
| C5775 | P5775 | Constipation Patient must be receiving palliative care. | |
| C5776 | P5776 | Terminal malignant neoplasia | |
| C5804 | P5804 | Megacolon |
Schedule 4, Part 1, entry for Tamoxifen
substitute:
| Tamoxifen | C5621 | Breast cancer The condition must be hormone receptor positive. |
| C5730 | Breast cancer The condition must be hormone receptor positive. |
Schedule 4, Part 1, entry for Temazepam
substitute:
| Temazepam | P5610 | CN5610 | Insomnia Continuing treatment Patient must be receiving palliative care. | Compliance with Authority Required procedures |
| P5661 | CN5661 | Malignant neoplasia (late stage) | Compliance with Authority Required procedures | |
| P5662 | CN5662 | Insomnia Initial treatment, for up to 4 months Patient must be receiving palliative care. | Compliance with Authority Required procedures | |
| P5684 | CN5684 | Benzodiazepine dependence Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult; AND | Compliance with Authority Required procedures | |
| P5770 | CN5770 | Benzodiazepine dependence Patient must be receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities; AND | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Tenecteplase
substitute:
| Tenecteplase | C5783 | Acute myocardial infarction The treatment must be administrated within 12 hours of onset of attack. |
Schedule 4, Part 1, entry for Ticagrelor
substitute:
| Ticagrelor | C5746 | Acute coronary syndrome (myocardial infarction or unstable angina) The treatment must be in combination with aspirin. | Compliance with Authority Required procedures - Streamlined Authority Code 5746 |
Schedule 4, Part 1, after entry for Tiotropium
insert:
| Tiotropium with olodaterol | C5763 | Chronic obstructive pulmonary disease (COPD) Patient must have been stabilised on a combination of a long acting muscarinic antagonist and long acting beta-2 agonist. | Compliance with Authority Required procedures - Streamlined Authority Code 5763 |
Schedule 4, Part 1, entry for Tipranavir
substitute:
| Tipranavir | C5764 | HIV infection The treatment must be in addition to optimised background therapy; AND | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5764 |
Schedule 4, Part 1, entry for Tirofiban
substitute:
| Tirofiban | C5691 | Non-Q-wave myocardial infarction | Compliance with Authority Required procedures - Streamlined Authority Code 5691 |
| C5782 | High risk of unstable angina Patient must have new transient or persistent ST-T ischaemic changes; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5782 |
| C5809 | High risk of unstable angina Patient must have new transient or persistent ST-T ischaemic changes; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5809 |
Schedule 4, Part 1, entry for Triglycerides, long chain with glucose polymer
omit:
| C1276 | Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae |
Schedule 4, Part 1, entry for Triglycerides, medium chain
(a)omit:
| C1068 | Chylothorax | Compliance with Authority Required procedures |
| C1511 | Long chain fatty acid oxidation disorders | Compliance with Authority Required procedures |
| C1513 | Hyperlipoproteinaemia type 1 | Compliance with Authority Required procedures |
| C1670 | Chylous ascites | Compliance with Authority Required procedures |
| C1671 | Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders | Compliance with Authority Required procedures |
| C1672 | Intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect, requiring a ketogenic diet | Compliance with Authority Required procedures |
substitute:
| C4379 | Chylothorax | Compliance with Authority Required procedures |
| C4393 | Chylous ascites | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C5616 | Intractable childhood epilepsy Patient must require a ketogenic diet. | Compliance with Authority Required procedures |
| C5690 | Fat malabsorption The condition must be due to liver disease; OR | Compliance with Authority Required procedures |
| C5723 | Hyperlipoproteinaemia type 1 | Compliance with Authority Required procedures |
| C5807 | Long chain fatty acid oxidation disorders | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Triglycerides—medium chain, formula
(a)omit:
| C1068 | Chylothorax | Compliance with Authority Required procedures |
| C1511 | Long chain fatty acid oxidation disorders | Compliance with Authority Required procedures |
| C1513 | Hyperlipoproteinaemia type 1 | Compliance with Authority Required procedures |
| C1670 | Chylous ascites | Compliance with Authority Required procedures |
| C1671 | Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C5644 | Chylothorax | Compliance with Authority Required procedures |
| C5645 | Long chain fatty acid oxidation disorders | Compliance with Authority Required procedures |
| C5693 | Fat malabsorption The condition must be due to liver disease; OR | Compliance with Authority Required procedures |
| C5726 | Chylous ascites | Compliance with Authority Required procedures |
| C5784 | Hyperlipoproteinaemia type 1 | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Triglycerides, medium chain and long chain with glucose polymer
substitute:
| Triglycerides, medium chain and long chain with glucose polymer | C4438 | Proven inborn errors of protein metabolism Patient must be unable to meet their energy requirements with permitted food and formulae. |
Schedule 4, Part 1, entry for Triptorelin
substitute:
| Triptorelin | C5646 | Locally advanced (stage C) or metastatic (stage D) carcinoma of the prostate | Compliance with Authority Required procedures - Streamlined Authority Code 5646 |
Schedule 4, Part 1, entry for Tropisetron
substitute:
| Tropisetron | C4077 | Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. |
| C5749 | Nausea and vomiting The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. |
Schedule 4, Part 1, entry for Umeclidinium with vilanterol
substitute:
| Umeclidinium with vilanterol | C5763 | Chronic obstructive pulmonary disease (COPD) Patient must have been stabilised on a combination of a long acting muscarinic antagonist and long acting beta-2 agonist. | Compliance with Authority Required procedures - Streamlined Authority Code 5763 |
Schedule 4, Part 1, entry for Ursodeoxycholic Acid
substitute:
| Ursodeoxycholic acid | C5757 | Primary biliary cirrhosis | Compliance with Authority Required procedures - Streamlined Authority Code 5757 |
Schedule 4, Part 1, entry for Vancomycin
substitute:
| Vancomycin | C5636 | Antibiotic associated pseudomembranous colitis The condition must be due to Clostridium difficile; AND | Compliance with Authority Required procedures |
| C5660 | Antibiotic associated pseudomembranous colitis The condition must be due to Clostridium difficile; AND | Compliance with Authority Required procedures | |
| C5716 | Endophthalmitis | ||
| C5717 | Endocarditis The treatment must be for prophylaxis; AND | ||
| C5769 | Infection The treatment must be initiated in a hospital; AND | ||
| C5801 | Endocarditis The treatment must be for prophylaxis; AND |
Schedule 4, Part 1, entry for Venlafaxine
substitute:
| Venlafaxine | C5650 | Major depressive disorders |
Schedule 4, Part 1, entry for Voriconazole
(a)omit:
| C4665 | P4665 | Serious Candida infections Treatment and maintenance therapy The condition must be caused by species not susceptible to fluconazole; OR | Compliance with Authority Required procedures |
| C4682 | P4682 | Definite or probable invasive aspergillosis Treatment and maintenance therapy Patient must be immunocompromised | Compliance with Authority Required procedures |
(b)omit:
| C4699 | Definite or probable invasive aspergillosis Treatment and maintenance therapy Patient must be immunocompromised | Compliance with Authority Required procedures | |
| C4722 | Serious Candida infections Treatment and maintenance therapy The condition must be caused by species not susceptible to fluconazole; OR | Compliance with Authority Required procedures | |
| C4723 | Serious invasive mycosis infections Treatment and maintenance therapy The treatment must be for invasive mycosis infections other than definite or probable invasive aspergillosis | Compliance with Authority Required procedures | |
| C4748 | P4748 | Serious fungal infections Treatment and maintenance therapy The condition must be caused by Scedosporium species or Fusarium species | Compliance with Authority Required procedures |
| C4749 | Serious fungal infections Treatment and maintenance therapy The condition must be caused by Scedosporium species or Fusarium species | Compliance with Authority Required procedures |
(c)insert in numerical order after existing text:
| C5624 | P5624 | Serious fungal infections Treatment and maintenance therapy The condition must be caused by Scedosporium species; OR | Compliance with Authority Required procedures |
| C5692 | P5692 | Serious Candida infections Treatment and maintenance therapy The condition must be caused by species not susceptible to fluconazole; OR | Compliance with Authority Required procedures |
| C5725 | P5725 | Definite or probable invasive aspergillosis Treatment and maintenance therapy Patient must be immunocompromised. | Compliance with Authority Required procedures |
| C5734 | P5734 | Serious invasive mycosis infections Treatment and maintenance therapy The treatment must be for invasive mycosis infections other than definite or probable invasive aspergillosis. | Compliance with Authority Required procedures |
| C5748 | P5748 | Serious fungal infections Treatment and maintenance therapy The condition must be caused by Scedosporium species; OR | Compliance with Authority Required procedures |
| C5813 | P5813 | Definite or probable invasive aspergillosis Treatment and maintenance therapy Patient must be immunocompromised. | Compliance with Authority Required procedures |
| C5814 | P5814 | Serious Candida infections Treatment and maintenance therapy The condition must be caused by species not susceptible to fluconazole; OR | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Ziprasidone
substitute:
| Ziprasidone | C4246 | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 4246 |
| C5742 | Acute mania or mixed episodes The condition must be associated with bipolar I disorder; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5742 |
Schedule 4, Part 1, entry for Zoledronic acid
substitute:
| Zoledronic acid | C5605 | Bone metastases The condition must be due to breast cancer. | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5605 |
| C5606 | Bone metastases The condition must be due to castration-resistant prostate cancer. | Compliance with Written or Telephone Authority Required procedures | |
| C5656 | Corticosteroid-induced osteoporosis Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5656 | |
| C5676 | Multiple myeloma | Compliance with Written or Telephone Authority Required procedures | |
| C5677 | Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy. | Compliance with Written or Telephone Authority Required procedures | |
| C5703 | Bone metastases The condition must be due to castration-resistant prostate cancer. | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5703 | |
| C5704 | Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy. | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5704 | |
| C5710 | Symptomatic Paget disease of bone Only 1 treatment each year per patient will be PBS-subsidised | Compliance with Authority Required procedures - Streamlined Authority Code 5710 | |
| C5735 | Multiple myeloma | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5735 | |
| C5736 | Bone metastases The condition must be due to breast cancer. | Compliance with Written or Telephone Authority Required procedures | |
| C5765 | Osteoporosis Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5765 | |
| C5796 | Established osteoporosis Patient must have fracture due to minimal trauma; AND | Compliance with Authority Required procedures - Streamlined Authority Code 5796 |
After Schedule 4, Part 2, insert Schedule 5
Schedule 5—Schedule equivalent
(section 8A)
| Listed Drug | Schedule Equivalent Group | Form | Manner of Administration | Brand | |||||
| Ondansetron | GRP-15983 | Tablet (orally disintegrating) 4 mg | Oral | Ondansetron AN ODT Ondansetron ODT-DRLA Ondansetron SZ ODT Onsetron ODT 4 Ondansetron AN ODT Ondansetron ODT-DRLA Ondansetron SZ ODT Onsetron ODT 4 Zilfojim ODT 4 | |||||
| Wafer 4 mg | Oral | Ondaz Zydis Zofran Zydis | |||||||
| GRP-15402 | Tablet (orally disintegrating) 8 mg | Oral | Ondansetron AN ODT Ondansetron ODT-DRLA Ondansetron SZ ODT Onsetron ODT 8 Ondansetron AN ODT Ondansetron ODT-DRLA Ondansetron SZ ODT Onsetron ODT 8 Zilfojim ODT 8 | ||||||
| Wafer 8 mg | Oral | Ondaz Zydis Zofran Zydis | |||||||
| Rizatriptan | GRP-17623 | Tablet (orally disintegrating) 10 mg (as benzoate) | Oral | Rizatriptan AN ODT | |||||
| Wafer 10 mg (as benzoate) | Oral | Maxalt Rizatriptan Wafers-10mg | |||||||
| Sumatriptan | GRP-15928 | Tablet 50 mg (as succinate) | Oral | APO-Sumatriptan Chem mart Sumatriptan Imigran Iptam Pharmacor Sumatriptan 50 Sumagran Aspen 50 Sumatab Sumatran Sumatriptan AN Sumatriptan RBX Sumatriptan Sandoz Sumatriptan generichealth Sumatriptan-GA Terry White Chemists Sumatriptan | |||||
| Tablet (fast disintegrating) 50 mg (as succinate) | Oral | Imigran FDT | |||||||
| Zoledronic Acid | GRP-17614 | Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL | Injection | APO-Zoledronic Acid DBL Zoledronic Acid Zometa | |||||
| Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL | Injection | DBL Zoledronic Acid Zometa | |||||||
0
0
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