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...
17 April 2021 SAHPRA has engaged with the Sisonke Phase 3B Implementation Study team and Janssen Pharmaceutica. The focus of the engagement was on the safety data reported from the Sisonke study, following administration of the COVID-19 vaccine Janssen, as well as the adverse events reported...
13 April 2021 We have noted the decision taken by the Food and Drug Administration in the United States of America to advise the temporary suspension of the Johnson and Johnson vaccine rollout in the US. This has occurred to due reports of 6 females who developed...
9 April 2021 On 6 April 2021 the Pretoria High Court issued a court order pertaining to four cases that were brought against SAHPRA and the Minister of Health regarding access to Ivermectin for use in COVID-19. The court order was as a result of settlement...
03 February 2021 There is an erroneous notion that SAHPRA “buckled under pressure” as a consequence of the court action brought by, amongst others the Afriforum regarding access to Ivermectin. SAHPRA wishes to state unequivocally that this is NOT the case. The court deliberations of 2 February...
28 January 2021 The second wave of the COVID-19 epidemic in South Africa has put enormous pressure on all aspects of South Africa’s health system and on its communities. SAHPRA appreciates the frustration and pain experienced by healthcare practitioners, patients and families given the limited availability...
27 January 2021 In an effort to enable and support the country’s response in fighting the COVID-19 pandemic, SAHPRA has on 22 January 2021 granted a Section 21 authorisation to the Department of Health for COVISHIELD (a covid-19 vaccine manufactured by Serum Institute of India) for...
22 December 2020 Post Importation Testing Exemptions (PITE) granted due to COVID-19 pandemic Post importation testing exemption approvals granted since March 2020 due to the Covid-19 pandemic, are extended to 30 April 2021 without further need of an application thereof. The initial approval date was extended to...
30 March 2020 In line with the recommendation of the South African National Institute for Communicable Disease (NICD) and the recommendation of the World Health Organization (WHO), SAHPRA wishes to point out that the so-called Rapid test kits (serological test kits) that are being offered...
The South African Health Products Regulatory Authority (SAHPRA) has become aware of reports on social media, which raise questions about whether non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, could worsen coronavirus disease (COVID-19) when used for the symptomatic treatment of pain and fever in patients...
