Committees

Published: 27 November 2015

Agenda for the 164th meeting of the Medicines Adverse Reactions Committee to be held at The Rydges, 75 Featherston Street, Pipitea, Wellington on Thursday 3 December 2015, at 9 am

1

Matters of Administration

1.1

Welcome and apologies

1.2

Minutes of the 163rd MARC meeting

1.3

Declaration of potential conflicts of interest

2

Medsafe Pharmacovigilance Activities

2.1

Report on standing agenda items

2.2

Medsafe pharmacovigilance activities

2.3

Prescriber Update

2.4

Quarterly summary of Medsafe early warning system communications

3

Pharmacovigilance Reports

3.1

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

No items.

3.2

Matters referred to the MARC by Medsafe

3.2.1

Gardasil and complex regional pain syndrome, postural orthostatic tachycardia syndrome and other concerns

3.2.2

 Inhaled corticosteroids and pneumonia

3.2.3

Hormone replacement therapy and risk of ovarian cancer

3.2.4

Epoetin beta and increased risk of retinopathy in preterm infants

3.2.5

Oral contraceptives containing drospirenone or dienogest and risk of VTE

4

Matters Arising from the NZ Pharmacovigilance Centre

4.1

CARM Quarterly Report

5

Other Business

5.1

Therapeutic products regulation project - update

5.2

Celebration of 50 years of spontaneous adverse reaction reporting (CARM)