SAHPRA office closure during festive season
SAHPRA offices will be closed for the festive season from 12:00 on Friday, 22 December 2023 and will...
29 November, 23Looking for a document – search here:
News and Updates
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SAHPRA encourages reporting side effects this MedSafetyWeek
Pretoria, 06 November 2023 – The South African Health Products Regulatory Authority (SAHPRA) is urgi...
06 November, 23 -
Launching SAHPRA’s Chatbot – meet Reggie!
The South African Health Products Regulatory Authority (SAHPRA) has launched its very own chatbot, R...
03 November, 23 -
Update on COVID-19 vaccines
Pretoria, 26 October 2023 – The South African Health Products Regulatory Authority (SAHPRA) currentl...
26 October, 23
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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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 -
The Metformin-containing Medicines That Are Registered And In Process
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulat...
12 October, 20 -
The Ranitidine-containing Medicines That Are Registered And In Process
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulat...
12 October, 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
Champix 0,5 mg and 1,0 mg (varenicline) film coated Tablets – combo
Following Test results that indicated levels of increased N-nitroso-varenicline that exceed the Acceptable Daily Intake (ADI) threshold of 733 ng/day calculated by Pfizer, based on ICH M7 guidance, Pfizer Laboratories (Pty) Ltd in South Africa took the decision to initiate a voluntary recall on Champix, batch 18069 and notified SAHPRA Regulatory Compliance Units. Recall process: Recall letter distributed to all healthcare professionals via medpages.
ZAARIO 50 and ZAARIO 100 film coated Tablets (lorsatan potassium)
The products are being recalled due to quality defect: the presence of a mutagenic impurity above the threshold limit observed during analysis, as requested by the European Directorate for the Quality of Medicines and Healthcare (EDQM) on new Azido impurities [the presence of Azido (5-AMBBT) mutagesic impurity beyond total threshold limit was observed during analysis].
Clonam 0.5 mg and Clonam 2 mg film coated Tablets (clonazepam)`
The products are being recalled due to quality defect: the tablet description should be cross-scored, but instead the tablet has only a single score.
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