Published: 29 November 2018

Committees

Agenda for the 176th meeting of the Medicines Adverse Reactions Committee to be held on Thursday 6 DECEMBEr 2018, at 9 am

1.

MATTERS OF ADMINISTRATION

1.1

Welcome and apologies

1.2

Minutes and recommendations of the 175th 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

  No items

3.2

Matters referred to the MARC by Medsafe

3.2.1  Hydrochlorothiazide (HCTZ) and Non-Melanoma Skin Cancer (NMSC)

3.2.2  Viekira Pak/Viekira Pak-RBV and psychiatric changes

3.2.3  Dose reductions for Pradaxa (dabigatran etexilate):  DVT/PE indications

3.2.4 Fetal exposure to lithium during pregnancy

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

5.

OTHER BUSINESS

5.1

Signal management of ADRs when medicines are used during pregnancy

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