Schedule 1 Amendments
[1] Schedule 1, entry for Alprazolam in each of the forms: Tablet 1 mg; and Tablet 2 mg
omit:
| | | Alprazolam-GA | GN | MP NP | C1975 | | 50 | 2 | |
[2] Schedule 1, entry for Aspirin in the form Tablet 100 mg
omit:
| | | DBL Aspirin 100 mg | GY | MP NP | | | 112 | 1 | |
[3] Schedule 1, entry for Atropine
substitute:
Atropine | Injection containing atropine sulfate 600 micrograms in 1 mL | Injection | Pfizer Australia Pty Ltd | PF | PDP | | | 10 | 0 | |
| | | | | MP NP | | | 10 | 1 | |
| Eye drops containing atropine sulfate 10 mg per mL, 15 mL | Application to the eye | Atropt | SI | MP NP | | | 1 | 2 | |
[4] Schedule 1, omit entry for Copper Sulfate
[5] Schedule 1, entry for Diazepam in the form Tablet 2 mg
(a) insert in the columns in the order indicated after the first instance of the brand “Antenex 2”:
| | | APO-Diazepam | TX | MP NP PDP | | | 50 | 0 | |
| | | | | MP NP | | P3656 | 50 | 0 | |
(b) insert in the columns in the order indicated after the second instance of the brand “Antenex 2”:
| | | APO-Diazepam | TX | MP NP | | P3655 | 50 | 3 | |
[6] Schedule 1, entry for Diazepam in the form Tablet 5 mg
(a) insert in the columns in the order indicated after the first instance of the brand “Antenex 5”:
| | | APO-Diazepam | TX | MP NP PDP | | | 50 | 0 | |
| | | | | MP NP | | P3656 | 50 | 0 | |
(b) insert in the columns in the order indicated after the second instance of the brand “Antenex 5”:
| | | APO-Diazepam | TX | MP NP | | P3655 | 50 | 3 | |
[7] Schedule 1, after entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL
insert in the columns in the order indicated:
| Solution concentrate for I.V. infusion 160 mg in 16 mL | Injection | DBL Docetaxel Concentrated Injection | HH | MP See Note 1 | C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428 | | 1 | 0 | |
[8] Schedule 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)
(a) insert in the columns in the order indicated, and in alphabetical order for the column head “Brand”:
| | | Escicor 10 | MI | MP NP | C1211 | | 28 | 5 | |
(b) insert in the columns in the order indicated, and in alphabetical order for the column head “Brand”:
| | | Pharmacor Escitalopram 10 | CR | MP NP | C1211 | | 28 | 5 | |
[9] Schedule 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)
(a) insert in the columns in the order indicated, and in alphabetical order for the column head “Brand”:
| | | Escicor 20 | MI | MP NP | C1211 | | 28 | 5 | |
(b) insert in the columns in the order indicated, and in alphabetical order for the column head “Brand”:
| | | Pharmacor Escitalopram 20 | CR | MP NP | C1211 | | 28 | 5 | |
[10] Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)
(a) omit:
| | | Fluoxebell | BF | MP NP | C1211 C1241 | | 28 | 5 | |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Fluoxetine RBX | RA | MP NP | C1211 C1241 | | 28 | 5 | |
[11] Schedule 1, entry for Folinic acid in the form Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Calcium Folinate Ebewe | IT | MP NP See Note 1 | | | 4 | 1 | |
[12] Schedule 1, after entry for Interferon Beta-1a in the form Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose pre-filled syringe
insert in the columns in the order indicated:
| Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose autoinjector | Injection | Rebif 44 | SG | MP | C1175 C1751 | | 12 | 5 | |
[13] Schedule 1, after entry for Levodopa with Carbidopa in the form Tablet 250 mg-25 mg (anhydrous)
insert in the columns in the order indicated:
| Intestinal gel 20 mg-5 mg per mL, 100 mL | Intra-intestinal | Duodopa | AB | MP NP | C3703 | | 56 | 5 | |
| | | | | MP
See Note 1 | C3704 C3705 | | 56 | 5 | C |
[14] Schedule 1, entry for Lisinopril in the form Tablet 10 mg
omit:
| | | Lisinopril Hexal | HX | MP NP | | | 30 | 5 | |
[15] Schedule 1, entry for Mefenamic Acid
omit from the column headed “Responsible Person”: PD and substitute: PF
[16] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | APO-Metformin 500 | TX | MP NP | | | 100 | 5 | |
[17] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | APO-Metformin 850 | TX | MP NP | | | 60 | 5 | |
[18] Schedule 1, entry for Morphine
substitute:
Morphine | Tablet containing morphine sulfate 10 mg | Oral | Sevredol | MF | MP NP | C1789 C3661 C3662 | P1789 P3662 | 20 | 0 | |
| | | | | MP NP | C1789 C3661 C3662 | P3661 | 20 | 2 | |
| Tablet containing morphine sulfate 20 mg | Oral | Sevredol | MF | MP NP | C1789 C3661 C3662 | P1789 P3662 | 20 | 0 | |
| | | | | MP NP | C1789 C3661 C3662 | P3661 | 20 | 2 | |
| Tablet containing morphine sulfate 30 mg | Oral | Anamorph | FM | MP NP PDP | C1358 | | 20 | 0 | |
| Tablet containing morphine sulfate 5 mg (controlled release) | Oral | MS Contin | MF | MP NP PDP | C1062 | | 28 | 0 | |
| Tablet containing morphine sulfate 10 mg (controlled release) | Oral | Momex SR 10 | SI | MP NP PDP | C1062 | | 28 | 0 | |
| | | MS Contin | MF | MP NP PDP | C1062 | | 28 | 0 | |
| Tablet containing morphine sulfate 15 mg (controlled release) | Oral | MS Contin | MF | MP NP PDP | C1062 | | 28 | 0 | |
| Tablet containing morphine sulfate 30 mg (controlled release) | Oral | Momex SR 30 | SI | MP NP PDP | C1062 | | 28 | 0 | |
| | | MS Contin | MF | MP NP PDP | C1062 | | 28 | 0 | |
| Tablet containing morphine sulfate 60 mg (controlled release) | Oral | Momex SR 60 | SI | MP NP PDP | C1062 | | 28 | 0 | |
| | | MS Contin | MF | MP NP PDP | C1062 | | 28 | 0 | |
| Tablet containing morphine sulfate 100 mg (controlled release) | Oral | Momex SR 100 | SI | MP NP PDP | C1062 | | 28 | 0 | |
| | | MS Contin | MF | MP NP PDP | C1062 | | 28 | 0 | |
| Tablet containing morphine sulfate 200 mg (controlled release) | Oral | MS Contin | MF | MP NP | C1499 C3659 C3660 | P1499 P3660 | 28 | 0 | |
| | | | | MP NP | C1499 C3659 C3660 | P3659 | 28 | 2 | |
| Capsule containing morphine sulfate 10 mg (containing sustained release pellets) | Oral | Kapanol | GK | MP NP PDP | C1062 | | 20 | 0 | |
| Capsule containing morphine sulfate 20 mg (containing sustained release pellets) | Oral | Kapanol | GK | MP NP PDP | C1062 | | 20 | 0 | |
| Capsule containing morphine sulfate 30 mg (controlled release) | Oral | MS Mono | MF | MP NP PDP | C1062 | | 14 | 0 | |
| Capsule containing morphine sulfate 50 mg (containing sustained release pellets) | Oral | Kapanol | GK | MP NP PDP | C1062 | | 20 | 0 | |
| Capsule containing morphine sulfate 60 mg (controlled release) | Oral | MS Mono | MF | MP NP PDP | C1062 | | 14 | 0 | |
| Capsule containing morphine sulfate 90 mg (controlled release) | Oral | MS Mono | MF | MP NP PDP | C1062 | | 14 | 0 | |
| Capsule containing morphine sulfate 100 mg (containing sustained release pellets) | Oral | Kapanol | GK | MP NP PDP | C1062 | | 20 | 0 | |
| Capsule containing morphine sulfate 120 mg (controlled release) | Oral | MS Mono | MF | MP NP PDP | C1062 | | 14 | 0 | |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet | Oral | MS Contin Suspension 20 mg | MF | MP NP PDP | C1062 | | 28 | 0 | |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet | Oral | MS Contin Suspension 30 mg | MF | MP NP PDP | C1062 | | 28 | 0 | |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet | Oral | MS Contin Suspension 60 mg | MF | MP NP PDP | C1062 | | 28 | 0 | |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet | Oral | MS Contin Suspension 100 mg | MF | MP NP PDP | C1062 | | 28 | 0 | |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 200 mg per sachet | Oral | MS Contin Suspension 200 mg | MF | MP NP | C1499 | | 28 | 0 | |
| Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL | Oral | Ordine 2 | MF | MP NP PDP | C1358 | | 1 | 0 | |
| Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL | Oral | Ordine 5 | MF | MP NP PDP | C1358 | | 1 | 0 | |
| Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL | Oral | Ordine 10 | MF | MP NP PDP | C1358 | | 1 | 0 | |
| Injection containing morphine sulfate 10 mg in 1 mL | Injection | Hospira Pty Limited | HH | MP NP MW PDP | | | 5 | 0 | |
| Injection containing morphine tartrate 120 mg in 1.5 mL | Injection | Hospira Pty Limited | HH | MP NP | | | 5 | 0 | |
| Injection containing morphine sulfate 15 mg in 1 mL | Injection | Hospira Pty Limited | HH | MP NP MW PDP | | | 5 | 0 | |
| Injection containing morphine sulfate 30 mg in 1 mL | Injection | Hospira Pty Limited | HH | MP NP PDP | | | 5 | 0 | |
[19] 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 [with a Max Quantity 3 and Number of Repeats 10]
omit from the column headed “Authorised Prescriber”: MP and substitute: MP NP
[20] Schedule 1, entry for Pioglitazone in each of the forms: Tablet 15 mg (as hydrochloride); Tablet 30 mg (as hydrochloride); and Tablet 45 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Vexazone | AF | MP NP | C3540 C3541 C3542 | | 28 | 5 | |
[21] Schedule 1, entry for Ramipril in the form Capsule 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
[22] Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Acris Once-a-Week | AF | MP NP | C2645 C2646 C3070 | | 4 | 5 | |
[23] Schedule 1, after entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)
(a) insert in the columns in the order indicated after the first instance of the brand “Terbix 250”:
| | | Tinasil | AL | MP NP | C2191 C2865 C3244 | P2865 P3244 | 42 | 0 | |
(b) insert in the columns in the order indicated after the second instance of the brand “Terbix 250”:
| | | Tinasil | AL | MP NP | C2191 C2865 C3244 | P2191 | 42 | 1 | |
[24] Schedule 1, entry for Valaciclovir
(a) insert in the columns in the order indicated after brand “Valaciclovir SZ”:
| | | Valacor 500 | RA | MP NP | C3622 C3623 C3624 C3631 | P3623 P3624 | 30 | 5 | |
(b) insert in the columns in the order indicated after the third instance of the brand “Valaciclovir Sandoz”:
| | | Valacor 500 | RA | MP NP | C3622 C3623 C3624 C3631 | P3622 P3631 | 42 | 0 | |
(c) insert in the columns in the order indicated after the fourth instance of the brand “Valtrex”:
| | | Zelitrex | RE | MP See Note 1 | C1494 C3419 | | 500 | 2 | C |
[25] Schedule 3
omit:
FK | PharmaLink Pty Ltd | 62 116 935 758 |
substitute:
FK | Invida Australia Pty Ltd | 62 116 935 758 |
[26] Schedule 3
omit:
GY | Mayne Pharma International Pty Ltd | 88 007 870 984 |
[27] Schedule 3
omit:
PD | Pfizer Australia Pty Ltd | 50 008 422 348 |
[28] Schedule 4, Part 1, omit entry for Copper Sulfate
[29] Schedule 4, Part 1, entry for Levodopa with Carbidopa
insert after existing text in the columns in the order indicated:
| C3703 | P3703 | Maintenance therapy following treatment which was commenced in a hospital-based movement disorder clinic, of a patient with advanced Parkinson disease with severe disabling motor fluctuations not adequately controlled by oral therapy. | Compliance with Authority Required procedures |
| C3704 | P3704 | Where the patient is receiving treatment at/from a public hospital Management of advanced Parkinson disease in a patient with severe disabling motor fluctuations not adequately controlled by oral therapy.
Treatment must be commenced in a hospital-based movement disorder clinic | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3704
|
| C3705 | P3705 | Where the patient is receiving treatment at/from a private hospital Management of advanced Parkinson disease in a patient with severe disabling motor fluctuations not adequately controlled by oral therapy.
Treatment must be commenced in a hospital-based movement disorder clinic | Compliance with Written or Telephone Authority Required procedures |
1Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
See http://www.frli.gov.au.
