MCC approves drug combination to include PrEP

Organisation: Position: Deadline Date: Location:

At its 75th meeting on 27-28 November 2015, South Africa’s Medicines Control Council (MCC) approved the use of the fixed-dose combination of tenofovir disoproxyl fumarate and emtricitabine to include pre-exposure prophylaxis of HIV (also referred to as PrEP).

As the use of the fixed-dose combination of tenofovir disoproxyl fumarate and emtricibine represents a departure from the usual use of these antiretrovirals for the treatment of HIV infection, the MCC has also requested the applicants to implement a risk management plan, which requires applicants to provide prescribers with a detailed information pack, to gather data on adverse effects, and to report these to the MCC at 6-monthly intervals.

MCC material

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