Schedule 1 Amendments
[1] Schedule 1, entry for Alprazolam in each of the forms: Tablet 1 mg (Alprazolam-GA); and Tablet 2 mg (Alprazolam-GA)
omit from the column headed “Responsible Person”: GM and insert: GN
[2] Schedule 1, entry for Alprazolam in each of the forms: Tablet 1 mg; and Tablet 2 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Ralozam | GM | MP NP | C1975 | | 50 | 2 | |
[3] Schedule 1, after entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
insert in the columns in the order indicated:
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides | Oral powder 400 g (Neocate LCP + MCT) | Oral | Neocate LCP + MCT | SB | MP NP | C1687 C1688 C2805 C2806 C2807 C2808 C2809 C2810 | | 8 | 5 | |
[4] Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL
omit from the column headed “Brand”: APO-go and insert: Apomine
[5] Schedule 1, entry for Aspirin in the form Tablet 100 mg (DBL Aspirin 100 mg)
omit from the column headed “Responsible Person”: YT and insert: GY
[6] Schedule 1, entry for Aspirin in the form Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Mayne Pharma Aspirin | YT | MP NP | | | 112 | 1 | |
[7] Schedule 1, after entry for Aurothiomalate
insert in the columns in the order indicated:
Azacitidine | Powder for injection 100 mg | Injection | Vidaza | CJ | MP See Note 1 | See Note 3 | See Note 3 | See Note 3 | See Note 3 | D |
[8] Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate)
(a) insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Zithromax”:
| | | Zitrocin | GM | MP NP | C1405 C1838 C1839 | P1838 P1839 | 2 | 0 | |
(b) insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Zithromax”:
| | | Zitrocin | GM | MP NP | C1405 C1838 C1839 | P1405 | 2 | 2 | |
[9] Schedule 1, entry for Bethanechol
omit from the column headed “Responsible Person”: HA and insert: YN
[10] Schedule 1, entry for Cabergoline
omit:
| Tablet 500 micrograms | Oral | Dostinex | PF | NP | C1289 | | 2 | 0 | |
| | | | | MP | C1289 C2659 C2660 C2661 C2662 | P1289 | 2 | 0 | |
| | | | | MP | C1289 C2659 C2660 C2661 C2662 | P2659 P2660 P2661 P2662 | 8 | 5 | |
| | | Tinexa | SI | MP | C2659 C2660 C2661 C2662 | P2659 P2660 P2661 P2662 | 8 | 5 | |
substitute:
| Tablet 500 micrograms | Oral | Dostan | GM | NP | C1289 | | 2 | 0 | |
| | | | | MP | C1289 C2659 C2660 C2661 C2662 | P1289 | 2 | 0 | |
| | | Dostinex | PF | NP | C1289 | | 2 | 0 | |
| | | | | MP | C1289 C2659 C2660 C2661 C2662 | P1289 | 2 | 0 | |
| | | Dostan | GM | MP | C1289 C2659 C2660 C2661 C2662 | P2659 P2660 P2661 P2662 | 8 | 5 | |
| | | Dostinex | PF | MP | C1289 C2659 C2660 C2661 C2662 | P2659 P2660 P2661 P2662 | 8 | 5 | |
| | | Tinexa | SI | MP | C2659 C2660 C2661 C2662 | P2659 P2660 P2661 P2662 | 8 | 5 | |
[11] Schedule 1, entry for Cabergoline in each of the forms: Tablet 1 mg; and Tablet 2 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Cobasol | GM | MP NP | C1255 | | 30 | 5 | |
[12] Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent); and Powder for injection 2 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | DBL Cefepime | HH | MP NP | C1427 | | 10 | 0 | |
[13] Schedule 1, entry for Doxorubicin ─ Pegylated Liposomal
omit from the column headed “Responsible Person”: SH and insert: JC (twice occurring)
[14] Schedule 1, after entry for Duloxetine
insert in the columns in the order indicated:
Dutasteride | Capsule 500 micrograms | Oral | Avodart | GK | MP | C3667 | | 30 | 5 | |
[15] Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate
10 mg; and Tablet containing enalapril maleate 20 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
(b) omit:
[16] Schedule 1, entry for Famotidine
omit:
[17] Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 100 mg in 50 mL (Fluconazole Hexal)
omit from the column headed “Responsible Person”: SZ and insert: HX
[18] Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 100 mg in 50 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Fluconazole Sandoz | SZ | MP NP | C3613 C3614 C3615 C3616 C3617 C3618 | | 7 | 0 | |
[19] Schedule 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Fluvoxamine GA | GM | MP NP | C1211 C1241 | | 30 | 5 | |
[20] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Gemplan | WQ | MP See Note 1 | C1193 C1194 C1740 C2069 C2141 | | 4 | 2 | |
[21] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Gemplan | WQ | MP See Note 1 | C1193 C1194 C1740 C2069 C2141 | | 2 | 2 | |
[22] Schedule 1, entry for Hydrocortisone
omit:
| Eye ointment containing hydrocortisone acetate 5 mg per g, 5 g | Application to the eye | Hycor | SI | AO MP NP | | | 1 | 0 | |
[23] Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
[24] Schedule 1, entry for Lisinopril in the form Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Lisinopril Sandoz | SZ | MP NP | | | 30 | 5 | |
[25] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | APO-Metformin 1000 | TX | MP NP | | | 90 | 5 | |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Chem mart Metformin 1000 | CH | MP NP | | | 90 | 5 | |
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Terry White Chemists Metformin 1000 | TW | MP NP | | | 90 | 5 | |
[26] Schedule 1, entry for Nicotine
substitute:
Nicotine | Transdermal patch 24.9 mg | Transdermal | Nicorette Patch | JT | MP NP | C3042 C3447 C3448 | | 28 | 2 | |
| Transdermal patch 52.5 mg | Transdermal | Nicotinell Step 1 | NC | MP NP | C3447 C3448 | | 28 | 2 | |
| Transdermal patch 114 mg | Transdermal | Nicabate P | GC | MP NP | C3447 C3448 | | 28 | 2 | |
[27] Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)
(a) insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “APO-Ondansetron”:
| | | Ondansetron-DRLA | RZ | MP NP See Note 1 | C3050 C3611 See Note 2 | P3050 See Note 2 | 4 See Note 2 | 0 See Note 2 | |
(b) insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “APO-Ondansetron”:
| | | Ondansetron-DRLA | RZ | MP NP | C3050 C3611 | P3611 | 10 | 1 | |
[28] Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)
(a) insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “APO-Ondansetron”:
| | | Ondansetron-DRLA | RZ | MP NP See Note 1 | C3050 C3611 See Note 2 | P3050 See Note 2 | 4 See Note 2 | 0 See Note 2 | |
(b) insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “APO-Ondansetron”:
| | | Ondansetron-DRLA | RZ | MP NP | C3050 C3611 | P3611 | 10 | 1 | |
[29] Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Reaptan 5/5 | RX | MP NP | C3307 C3308 | | 30 | 5 | |
[30] Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Reaptan 5/10 | RX | MP NP | C3307 C3308 | | 30 | 5 | |
[31] Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Reaptan 10/5 | RX | MP NP | C3307 C3308 | | 30 | 5 | |
[32] Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Reaptan 10/10 | RX | MP NP | C3307 C3308 | | 30 | 5 | |
[33] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg
(a) insert in the columns in the order indicated, and in alphabetical after the first instance of the brand “Risperidone-GA”:
| | | Risperidone Sandoz | SZ | MP NP | C1589 C2061 C3083 | P2061 P3083 | 60 | 2 | |
(b) insert in the columns in the order indicated, and in alphabetical after the second instance of the brand “Risperidone-GA”:
| | | Risperidone Sandoz | SZ | MP NP | C1589 C2061 C3083 | P1589 | 60 | 5 | |
[34] Schedule 1, entry for Risperidone in the form Tablet 1 mg
(a) insert in the columns in the order indicated, and in alphabetical after the first instance of the brand “Risperidone generichealth”:
| | | Risperidone Sandoz | SZ | MP NP | C1589 C2061 C2272 C3083 | P2061 P3083 | 60 | 2 | |
(b) insert in the columns in the order indicated, and in alphabetical after the second instance of the brand “Risperidone generichealth”:
| | | Risperidone Sandoz | SZ | MP NP | C1589 C2061 C2272 C3083 | P1589 P2272 | 60 | 5 | |
[35] Schedule 1, entry for Risperidone in the form Tablet 2 mg
(a) insert in the columns in the order indicated, and in alphabetical after the first instance of the brand “Risperidone generichealth”:
| | | Risperidone Sandoz | SZ | MP NP | C1589 C2272 C3083 | P3083 | 60 | 2 | |
(b) insert in the columns in the order indicated, and in alphabetical after the second instance of the brand “Risperidone generichealth”:
| | | Risperidone Sandoz | SZ | MP NP | C1589 C2272 C3083 | P1589 P2272 | 60 | 5 | |
[36] Schedule 1, entry for Risperidone in the form Tablet 3 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Risperidone Sandoz | SZ | MP NP | C1589 C2272 | | 60 | 5 | |
[37] Schedule 1, entry for Risperidone in the form Tablet 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Risperidone Sandoz | SZ | MP NP | C1589 C2272 | | 60 | 5 | |
[38] Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Sertracor 50 | MI | MP NP | C1211 | | 30 | 5 | |
[39] Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Sertracor 100 | MI | MP NP | C1211 | | 30 | 5 | |
[40] Schedule 1, entry for Stavudine
omit:
| Powder for oral solution 1 mg per mL, 200 mL | Oral | Zerit | BQ | MP See Note 1 | C3586 C3587 C3588 C3589 | | 24 | 5 | D |
[41] Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Sumatriptan-GA | GM | MP NP | C3233 | | 4 | 5 | |
[42] Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg
omit from the column headed “Brand”: Tramahexal SR and insert: Tramadol Sandoz SR
[43] Schedule 1, entry for Trastuzumab
insert as first entry in the columns in the order indicated:
| Powder for I.V. infusion 60 mg | Injection | Herceptin | RO | MP See Note 1 | See Note 3 | See Note 3 | See Note 3 | See Note 3 | D |
[44] Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Valtrex”:
| | | Zelitrex | RE | MP NP | C3622 C3631 C3632 C3633 | P3632 | 20 | 0 | |
(b) insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Valtrex”:
| | | Zelitrex | RE | MP NP | C3622 C3631 C3632 C3633 | P3633 | 30 | 5 | |
(c) insert in the columns in the order indicated, and in alphabetical order after the third instance of the brand “Valtrex”:
| | | Zelitrex | RE | MP NP | C3622 C3631 C3632 C3633 | P3622 P3631 | 42 | 0 | |
[45] Schedule 1, entry for Vancomycin in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Vancocin CP”:
| | | Vancomycin Alphapharm | AF | MP | C1091 C1302 C1464 | P1302 | 2 | 0 | |
| | | | | PDP | C1302 | | 2 | 0 | |
(b) insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Vancocin CP”:
| | | Vancomycin Alphapharm | AF | MP | C1091 C1302 C1464 | P1091 P1464 | 5 | 0 | |
[46] Schedule 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)
(a) insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Hospira Pty Limited”:
| | | Vancomycin Alphapharm | AF | MP | C1091 C1302 C1464 | P1302 | 1 | 0 | |
| | | | | PDP | C1302 | | 1 | 0 | |
(b) insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Hospira Pty Limited”:
| | | Vancomycin Alphapharm | AF | MP | C1091 C1302 C1464 | P1091 P1464 | 3 | 0 | |
[47] Schedule 1, entry for Varenicline
omit:
| Tablet 1 mg (as tartrate) | Oral | Champix | PF | MP NP | C2776 | | 112 | 0 | |
substitute:
| Tablet 1 mg (as tartrate) | Oral | Champix | PF | MP NP | C3670 C3671 | P3671 | 56 | 2 | |
| | | | | MP NP | C3670 C3671 | P3670 | 112 | 0 | |
[48] Schedule 3, after details relevant to Responsible person code GX
insert:
GY | Mayne Pharma International Pty Ltd | 88 007 870 984 |
[49] Schedule 3, details relevant to Responsible person code PL
omit:
insert:
| The Trustee for Virgo Unit Trust (trading as Phebra) | |
[50] Schedule 3, after details relevant to Responsible person code RD
insert:
RE | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[51] Schedule 3, after details relevant to Responsible person code RO
insert:
RX | Servier Laboratories (Aust.) Pty Ltd | 54 004 838 500 |
[52] Schedule 4, Part 1, after entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
insert in the columns in the order indicated:
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides | C1687 | | Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed | Compliance with Authority Required procedures |
| C1688 | | Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | Compliance with Authority Required procedures |
| C2805 | | Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2806 | | Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows' milk protein, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2807 | | Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2808 | | Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2809 | | Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
| C2810 | | Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application | Compliance with Authority Required procedures |
[53] Schedule 4, Part 1, after entry for Duloxetine
insert in the columns in the order indicated:
Dutasteride | C3667 | | Treatment, in combination with an alpha-antagonist, of lower urinary tract symptoms due to benign prostatic hyperplasia where treatment is initiated by a urologist | Compliance with Authority Required procedures - Streamlined Authority Code 3667 |
[54] Schedule 4, Part 1, entry for Nicotine
substitute:
Nicotine | C3042 | | Nicotine dependence in an Aboriginal or a Torres Strait Islander person as the sole PBS-subsidised therapy | Compliance with Authority Required procedures |
| C3447 | | Short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the initial authority application | Compliance with Authority Required procedures |
| C3448 | | Short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the initial authority application | Compliance with Authority Required procedures |
[55] Schedule 4, Part 1, entry for Varenicline
substitute:
Varenicline | C2774 | | Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the authority application | Compliance with Authority Required procedures |
| C2775 | | Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the authority application | Compliance with Authority Required procedures |
| C3670 | P3670 | Continuation of short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has previously been issued with an authority prescription for this drug and who is enrolled in a comprehensive support and counselling program | Compliance with Authority Required procedures |
| C3671 | P3671 | Completion of short-term sole PBS-subsidised therapy as an aid to achieving long-term abstinence after completion of an initial 12-week PBS-subsidised course in a patient who has ceased smoking, and who is enrolled in a comprehensive support and counselling program | Compliance with 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