Communication to industry on the sartans-containing medicines

Communication to industry on the sartans-containing medicines

The notice of concern for the above registered products refers. The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing all sartan-containing medicines with the following Active Pharmaceutical Ingredients; azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan and valsartan. SAHPRA previously issued a press release regarding the recall of Pharma Dynamics DynavalCo range, containing the active ingredient, valsartan (23 July 2018) and a follow-up re-assurance on the safety of valsartan containing medicines registered in South Africa (20 December 2018). A communication to industry has also been published titled: request to industry on the sartan-containing medicines that are in-process and registered in South Africa (06 August 2019).

2020 Oct

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File Type: pdf
Category: Communication to industry
Unit: General ECTD & human medicines