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Scheduling delegate's final decisions, June 2017

Scheduling medicines and poisons

29 June 2017

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1. Summary of delegate's final decisions

Part A - Final decisions on matters referred to an expert advisory committee (March 2017)

Advisory Committee on Medicines Scheduling (ACMS #20)

1. Summary of delegate's final decisions

The implementation date for the following decisions is 1 October 2017 unless otherwise indicated.

Substance Final decision

Dihydrocodeine

Schedule 8 – Amend Entry

DIHYDROCODEINE except when included in Schedule 3 or 4.

Schedule 4 – Amend Entry

DIHYDROCODEINE when compounded with one or more other therapeutically active substances:

  1. in divided preparations containing not more than 100 mg of dihydrocodeine per dosage unit; or
  2. in undivided preparations with a concentration of not more than 2.5 per cent of dihydrocodeine,

except when included in Schedule 3.

Schedule 3 – Amend Entry

DIHYDROCODEINE when indicated for cough suppression and compounded with one or more other therapeutically active substances:

  1. in divided preparations containing 10 mg or less of dihydrocodeine per dosage unit and with a recommended dose not exceeding 15 mg of dihydrocodeine; or
  2. in undivided preparations containing 0.25 per cent or less of dihydrocodeine with a recommended dose not exceeding 15 mg of dihydrocodeine.

Schedule 2 – Delete Entry

1,3-Dimethylbutylamine (DMBA) and other aliphatic alkylamines including 1,5-dimethylhexylamine (DMHA)

Schedule 10 – New Entries

1,3-DIMETHYLBUTYLAMINE (DMBA) except when separately specified in these schedules.

1,5-DIMETHYLHEXYLAMINE (DMHA) except when separately specified in these schedules.

ALKYLAMINES WITH STIMULANT PROPERTIES except when separately specified in these schedules.

Index – New Entries

1,3-DIMETHYLBUTYLAMINE (DMBA)
cross reference: octodrine, 1-aminoisoheptane, DMHA, 1,5-dimethylhexylamine, 4-methylhexane-2-amine, 1,3-dimethylamylamine, DMAA, 4-amino-2-methylpentane Citrate (AMP Citrate)

Schedule 10

1,5-DIMETHYLHEXYLAMINE (DMHA)
cross reference: 1,3-dimethylbutylamine, DMBA, octodrine, 1-aminoisoheptane, DMHA, 4-methylhexane-2-amine, 1,3-dimethylamylamine, DMAA, 4-amino-2-methylpentane Citrate (AMP Citrate)

Schedule 10

ALKYLAMINES WITH STIMULANT PROPERTIES
cross reference: 1,3-dimethylbutylamine, DMBA, octodrine, 1-aminoisoheptane, DMHA, 1,5-dimethylhexylamine, 4-methylhexane-2-amine, 1,3-dimethylamylamine, DMAA, 4-amino-2-methylpentane citrate (AMP citrate)

Schedule 10

Ulipristal

Schedule 3

ULIPRISTAL for emergency post-coital contraception.

Appendix H – New Entry

ULIPRISTAL for emergency post-coital contraception

Index – Amend Entry

ULIPRISTAL

Schedule 4
Schedule 3
Appendix H

The implementation date is 1 February 2018.

Ibuprofen

Schedule 3 – Amend Entry

IBUPROFEN:

  1. in divided preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 50 dosage units, when labelled:
    1. with a recommended daily dose of 1200 mg or less of ibuprofen; and
    2. not for the treatment of children under 12 years of age; or
  2. in a modified release dosage form, each containing 600 mg of ibuprofen in a primary pack containing not more than 32 dosage units, when labelled:
    1. with a recommended daily dose of 1200 mg or less of ibuprofen; and
    2. not for the treatment of children under 12 years of age,

except when included in or expressly excluded from Schedule 2.

Appendix H – New Entry

IBUPROFEN

Flurbiprofen

The delegate's final decision is that the current scheduling of flurbiprofen remains appropriate.

Penciclovir

Schedule 4 –Amend Entry

PENCICLOVIR except in preparations containing 1 per cent or less of penciclovir for the treatment of herpes labialis in packs containing 10 g or less.

Schedule 2 – Delete Entry

Index – Amend Entry

PENCICLOVIR

Schedule 4

Loratadine

Schedule 4 – Amend Entry

LORATADINE except:

  1. when included in Schedule 2; or
  2. in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 6 years of age and over, when:
    1. in a primary pack containing 10 dosage units or less; and
    2. labelled with a recommended daily dose not exceeding 10 mg of loratadine.

Schedule 2 – Amend Entry

LORATADINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis when:

  1. in a primary pack containing 10 dosage units or less when labelled for adults and children 6 years and over; and
  2. labelled with a recommended daily dose not exceeding 10 mg of loratadine.

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