You are here

Final scheduling decisions and reasons: NCEs and Appendix H

Part A - Final decisions on matters not referred to an expert advisory committee

12 December 2018

Book pagination

2.2. Brigatinib

2. New Chemical Entities – medicines for human therapeutic use

2.2. Brigatinib

Delegate's final decision
Final decision:

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

Schedule 4 - New Entry

BRIGATINIB

Index - New Entry

BRIGATINIB

Schedule 4

Proposed implementation date:

1 February 2019

Reasons:

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

  1. the risks and benefits of the use of a substance:

    The risks and benefits of the medicine require assessment by a medical practitioner experienced in the treatment of the condition

  2. the purposes for which a substance is to be used and the extent of use of a substance:

    The diagnosis, management and monitoring of the clinical condition require expert medical assessment and review

  3. the toxicity of a substance:

    The safety profile of the medicine requires expert medical assessment and monitoring

  4. the dosage, formulation, labelling, packaging and presentation of a substance:

    Nil

  5. the potential for abuse of a substance:

    Nil

  6. any other matters that the Secretary considers necessary to protect public health:

    Nil

Applicant's scheduling proposal and reasons for proposal

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

Current scheduling status

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

Delegate's considerations

The delegate considered the following in regards to this scheduling:

  • Subsection 52E(1) of the Therapeutic Goods Act 1989;
  • The Scheduling Policy Framework (2018) scheduling factors;
  • Advice on the place in therapy of this NCE.

Book pagination