Update: Feedback on SAHPRA’s EOIs and latest appointments
The South African Health Products Regulatory Authority (SAHPRA) has published four (4) Expression of...
21 February, 25
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News and Updates
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Landmark agreement among Africa’s leading National Medicines Regulatory Authorities to foster collaboration
Cairo, Egypt, 4 February 2025: The Africa Centres for Disease Control and Prevention (Africa CDC) an...
05 February, 25 -
South Africa-WHO gears up to map way forward to fight substandard and falsified medical products
Pretoria – The leading agencies, the South African Health Products Regulatory Authority (SAHPR...
04 February, 25 -
SAHPRA clarifies the benefits and risks of medroxyprogesterone acetate
Pretoria, 17 January 2025 – The South African Health Products Regulatory Authority (SAHPRA) has reco...
17 January, 25
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Databases and Registers
OTC Medicine Information
The Medicines’ Online Directory provides healthcare professionals and the consumer with a guide to all SAHPRA registered over-the counter (OTC) medicines that are available in South Africa without a doctor’s prescription.
Safety alerts
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IV Tranexamic acid – Administration error via the intrathecal route
There have been several cases around the world in which Tranexamic acid has been administered intrat...
21 December, 23 -
A Signal Of Myocarditis / Pericarditis Associated With Pfizer-biontech’s Covid-19 Vaccine, Comirnaty (Bnt162b2)
The South African Health Products Regulatory Authority (SAHPRA) would like to inform you of a signal...
19 October, 21 -
Risk of Drug-Induced Liver Injury associated with the use of Esbriet®
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Roche Product...
10 November, 20 -
MSA Diphenhydramine-containing Medicines
SAHPRA alerts all healthcare professionals about the risk of serious heart problems, seizures, coma ...
01 November, 20
Whistleblower
The hotline has been established with the aim of enhancing an honest work ethic and simultaneously providing the public with a mechanism to bring any unethical business practices to the attention of management.
Product Recalls
An out-of-specification result for related substances observed during stability testing of batch GH21051.
An inadvertent inclusion of plasma from an unapproved supplier in the formulation, which was not detected at the time of batch release.
The recall is initiated because some units of the batch presented with low fill volumes, and therefore does not meet the final product specifications with respect to the volume.
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