South African and Australian health product regulators to share regulatory information and expertise
Pretoria, South Africa and Canberra, Australia, 07 October 2024 –The South African Health Products R...
07 October, 24
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News and Updates
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Feedback on SAHPRA’s EOIs and latest appointments
The South African Health Products Regulatory Authority (SAHPRA) has published four (4) Expression of...
20 September, 24 -
SAHPRA attains clean audit outcome for the 2023/2024 financial year
Pretoria, 16 September 2024 –The South African Health Products Regulatory Authority (SAHPRA) is prou...
16 September, 24 -
SAHPRA dismisses unfounded misinformation campaign deliberately misrepresenting its draft B-BBEE Policy by some sectors of society and media organisations
Pretoria, 22 July 2024 –The South African Health Products Regulatory Authority (SAHPRA) is disappoin...
22 July, 24
Media
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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
Coralan 7.5 mg Tablets (Ivabradine 7.5mg)
This recall was initiated as a result of a product packaging mistake lodged with Servier Laboratories. Some of the cartons (boxes) are incorrectly printed on the side panel, but the tablets inside the blisters are the correct tablets according to the carton.
Dovate Cream (Clobetasol Propionate)
This recall was initiated because of the compromised package integrity on some of the tubes. The tubes were damaged by packaging equipment during the packing process causing part of the upper portion of the tubes to be split open.
Zinium Infant Drops
This recall was initiated as a potential quality defect was identified.
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