South African Medicines Control Council approves tenofovir/FTC for PrEP

1 February 2016. Related: HIV prevention and transmission.

Simon Collins, HIV i-Base

On 3 December 2015 the South African Medicines Control Council (MCC) approved a fixed dose formulation of tenofovir DF/FTC for HIV preexposure prophylaxis (PrEP).

Although limited details were provided, the MCC also requested a risk management plan, to collect safety data on side effects, and to report these every six months.

The Medicines Control Council (MCC) is responsible for regulating all medicines and medical devices in South Africa.

Reference:

MCC press release. Medicines Control Council approves fixed-dose combination of tenofovir disoproxil fumarate and emtricitabine for pre-exposure prophylaxis of HIV. (3 December 2015).
http://www.mccza.com
http://www.mccza.com/documents/2e4b3a5310.11_Media_release_ARV_FDC_PrEP_Nov15_v1.pdf (PDF)