Published: 16 October 2019

Committees

Medicines Assesment Advisory Committee

Agenda for the 108th meeting of the Medicines Assessment Advisory Committee to be held on 13 November 2019 at 9:30 am

1

Welcome

2

Apologies

3

Confirmation of the minutes of the 107th meeting held on 11 december 2018

4

Declaration of conflicts of interest

5

Applications for consent to distribute a new medicine under section 20 / 23 / 24 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2))

5.1

Clonazepam tablets, 0.5 mg and 2 mg strength (TT50-9877)

 Boucher & Muir Pty Ltd

The product is an intermediate-risk, generic prescription medicine proposed for the treatment of most clinical forms of epilepsy in infants and children, in particular typical and atypical absences (Lennox-Gastaut syndrome), nodding spasms, primary or secondary generalised tonic-clonic seizures. The product may also be used in epilepsy of adults and in focal seizures.  

The application was received by Medsafe on 27 October 2015. The application has undergone three rounds of requests for information and issues remain unresolved. Medsafe is unable to recommend that the benefits outweigh the risks presented by the unresolved issues.  

The application is being referred to the Committee for independent advice as to whether the Minister of Health should grant consent.

6

Review of evaluation reports

7

General business

8

Date of next meeting

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