Committees

Published: 20 June 2018

Agenda for the 174th meeting of the Medicines Adverse Reactions Committee to be held on TUESDAY 3 JULY 2018, at 9 am

1.

MATTERS OF ADMINISTRATION

1.1

Welcome and apologies

1.2

Minutes and recommendations of the 173rd MARC meeting

1.3

Declarations of potential conflicts of interest

2.

MATTERS ARISING FROM THE NZ PHARMACOVIGILANCE CENTRE

2.1

CARM quarterly report

3.

PHARMACOVIGILANCE REPORTS

3.1

Matters referred to the MARC under section 36 of the Medicines Act 1981

  3.1.1 Consideration of Esmya (ulipristal acetate) under section 36 of the Medicines Act 1981

3.2

Matters referred to the MARC by Medsafe

 

3.2.1  Bexsero (recombinant Meningococcal group B vaccine) RMP

3.2.2  Atypical antipsychotics and sleepwalking/sleep-related eating disorder

3.2.3  Potential drug interaction between nefopam and tramadol

3.2.4 Isotretinoin: review of (1) pregnancy prevention measures and (2) obsessive compulsive disorder

4.

MEDSAFE PHARMACOVIGILANCE ACTIVITIES

4.1

Report on standing agenda items

4.2

Medsafe pharmacovigilance activities

4.3

Prescriber Update

4.4

Quarterly summary of recent safety communications