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Welcome

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Apologies

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Declaration of conflicts of interest

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Applications for consent to distribute a new medicine under section 20 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2))

4.1

Zolgensma, onasemnogene abeparavovec (2 x 10¹³ vg/mL), solution for infusion (Novartis New Zealand Ltd).

Zolgensma is a solution for infusion containing the active ingredient onasemnogene abeparvovec (2 x 10¹³ vg/mL) and is presented in two vial presentations: 1.1 x 10¹⁴ vg in 5.5 mL (not supplied alone) and 1.7 x10¹⁴ vg in 8.3 mL. Zolgensma is indicated for the treatment of paediatric patients with spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene. Zolgensma is for one-time dosing.

This application is being referred to the Committee for independent advice as to whether the Minister of Health (or their delegate) should grant consent for sale, supply and distribution of the proposed product in Aotearoa New Zealand.

4.2

Paracetamol (Home Brand), capsule, powder filled 500 mg (Nova Pharmaceuticals Australasia Pty Ltd.

Paracetamol (Home Brand) is a generic medicine containing 500 mg paracetamol per capsule.

A changed medicine notification (CMN) was submitted to Medsafe to update product particulars. This has been referred to the Minister of Health for consideration of approval under section 24(5) of the Medicines Act 1981.

This application is being referred to the Committee for independent advice as to whether the Minister of Health (or their delegate) should grant consent for sale, supply and distribution of the proposed product in Aotearoa New Zealand.

4.3

Review of Medicine Evaluations

A term of reference for the Medicine Assessment Advisory Committee (the Committee) is that the Committee should review evaluation reports and provide expert advice to Medsafe and the Minister of Health as to the quality of the risk-benefit assessments that have been completed.

The Committee will review the evaluation reports of eight applications for the Minister of Health’s consent or provisional consent for the distribution of new medicines.

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GENERAL BUSINESS

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DATE OF NEXT MEETING