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News and Updates


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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


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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