Pretoria, 15 May 2023 -The South Africa Health Products Regulatory Authority (SAHPRA) acknowledges and aligns itself to the statement issued by the World Health Organization (WHO) Director-General, declaring an end to the Public Health Emergency of International Concern (PHEIC) for the disease caused by the...
Pretoria, 21 April 2023 - The South African Health Products Regulatory Authority (SAHPRA) issued media statements on 4 August 2022 and 12September 2022, relating to two fatal cases of Guillain-Barré syndrome (GBS) following vaccination with COVID-19 Vaccine Janssen. SAHPRA has been informed of a third...
Pretoria, 06 April 2023 – The South African Health Products Regulatory Authority (SAHPRA) has made the decision to withdraw pholcodine-containing medicines from the South African (SA) market due to the increased risk of sudden, severe, and life-threatening allergic reactions occurring during surgery. There is a...
Pretoria, 30 January 2023 – The South African Health Products Regulatory Authority (SAHPRA) has registered Paxlovid, an anti-viral medicine manufactured by Pfizer, to treat COVID-19. Paxlovid, which contains Nirmatrelvir (150mg) and Ritonavir (100mg), is a medicine that is used for the treatment of mild to moderate...
Pretoria, 2 December 2022 – The South African Health Products Regulatory Authority (SAHPRA) has registered Cabotegravir (Apretude 600 mg/3ml injection), a long-acting HIV pre-exposure prophylactic. Cabotegravir is an antiretroviral drug (ARV) that people living with HIV may use, together with other ARVs, to keep the virus...
Pretoria, 2 December 2022 – With the establishment of the South African Health Products Regulatory Authority (SAHPRA) in February 2018, the regulatory authority inherited a backlog of approximately 16 000 new product and variation applications from its predecessor, the Medicines Control Council (MCC). As is generally...
Pretoria, 24 November 2022 – In the past year, the South African Health Products Regulatory Authority (SAHPRA) approved the antigen test kits for use by healthcare professionals. SAHPRA has now approved seven (7) COVID-19 antigen self-test kits that can be used as self-test/ at home tests...
Pretoria, 23 November 2022 – On 6 April 2021, the Pretoria High Court issued a consent court order pertaining to four cases that were brought against the South African Health Products Regulatory Authority (SAHPRA) and the Minister of Health regarding access to Ivermectin for use...
22 November 2022 Embargo: Immediate release Pretoria, 22 November 2022 - The South African Health Products Regulatory Authority (SAHPRA) has registered Pfizer’s COMIRNATY Ready To Use (RTU) ADULT VACCINE and Dilute To Use (DTU) PAEDIATRIC VACCINE on 15 November 2022. The RTU vaccine, as the name...
Pretoria, 4 November 2022 – The South African Health Products Regulatory Authority (SAHPRA) received an accolade from the National Press Club (NPC) on 3 November 2022 at a gala dinner event. “As was the case for many other organisations, the COVID-19 pandemic restricted the National Press...
