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Scheduling delegates' final decisions: NCEs, May 2018

Scheduling medicines and poisons

19 June 2018

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1.6 Idebenone

New Chemical Entities - medicines for human therapeutic use

1.6 Idebenone

Delegate's final decision
Final decision:

The delegate's final decision is to amend the Poisons Standard to include idebenone in Schedule 4 as follows:

Schedule 4 - New Entry

IDEBENONE.

Implementation date: 1 June 2018
Reasons:

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:

  1. the risks and benefits of the use of a substance
    • Idebenone is a new chemical entity with no marketing experience in Australia.
  2. the purposes for which a substance is to be used and the extent of use of a substance
    • The diagnosis, treatment and monitoring of patients with Duchenne Muscular Dystrophy condition should be supervised by a medical practitioner experienced in managing this condition.
  3. the toxicity of a substance
    • Idebenone has a potential for adverse effects, requiring monitoring by a medical practitioner.
  4. the dosage, formulation, labelling, packaging and presentation of a substance
    • Labelling needs to comply with the requirements for a Prescription-Only Medicine.
  5. the potential for abuse of a substance
    • Idebenone has a low potential for abuse.
Scheduling proposal

The delegate of the Secretary proposed to amend the Poisons Standard with respect to idebenone.

Scheduling status

Idebenone is not specifically scheduled and is not captured by any entry in the Poisons Standard.

Delegate's consideration
  • Scheduling Policy Framework (SPF 2018); and
  • Section 52E(1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse of a substance.

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