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Update on the review of CEP applications for sartans

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Certification of suitability (CEP)
CEP suspension
News
19 November 2018
Strasbourg, France

Following new information recently received by EDQM about the detection of low levels of N-nitrosodiethylamine (NDEA) in Valsartan manufactured by MYLAN LABORATORIES Ltd , the EDQM has immediately suspended the certificate of suitability (CEP) R1-CEP 2009-396-Rev 03/Valsartan held by this company, until appropriate corrective actions are taken.

This is part of the on-going review of the manufacturing information submitted in all CEP applications for valsartan and other structurally related active substances. NDEA is classified as probable human carcinogen (substance that may cause cancer).

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