EMA recommendations on nitrosamine impurities in sartans
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EMA recommendations on nitrosamine impurities in sartans The European Medicines Agency (EMA) has aligned its recommendations on limiting nitrosamine impurities in sartans (angiotensin II receptor antagonists) with those for other classes of medicines. Nitrosamine limits which were previously applied to the active ingredients will now be applied to finished products such as tablets, to ensure that the risk of cancer from nitrosamines in sartans is less than one in 100 000 for patients receiving lifelong treatment. Manufacturers should use control strategies to prevent or limit the presence of nitrosamine impurities in sartans and, if necessary, improve their manufacturing processes. They should also evaluate the risk of nitrosamines in their medicines and perform appropriate testing. The revised conditions required for sartans brings them into line with those for other drug classes issued in June 2020. EMA’s Committee for Medicinal Products for Human Use (CHMP) initially started reviewing valsartan at the request of the European Commission in July 2018, and extended the review to include candesartan, irbesartan, losartan and olmesartan in September 2018. These five sartans contain a tetrazole group, the synthesis of which could potentially lead to the formation of nitrosamine impurities. This review was concluded in January 2019. Other sartans which do not have this ring structure, such as azilsartan, eprosartan and telmisartan, were not included in the review but were covered by a subsequent review of other medicines. The alignment of nitrosamine recommendations for sartans with those of other medicines was reported in meeting highlights from the CHMP at its November 2020 meeting. EMA. Nitrosamines: EMA aligns recommendations for sartans with those for other medicines. Internet Document : 16 Nov 2020. Available from: URL: https:// www.ema.europa.eu/en/news/nitrosamines-ema-aligns-recommendations-sartans-those-other-medicines
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Reactions 28 Nov 2020 No. 1832
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