Update on the review of CEP applications for sartans and the availability of test methods for nitrosamines

EDQM 17/10/2018 Strasbourg, France

Following the detection of the impurity NDMA (N-nitrosodimethylamine) in valsartan at the end of June, the EDQM has conducted a complete review of the manufacturing information submitted in all Certificate of suitability (CEP) applications for valsartan and other structurally related active...

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New OMCL method for simultaneous determination of NDMA and NDEA in sartans

EDQM 11/10/2018 Strasbourg, France

Since early July 2018 Official Medicines Control Laboratories (OMCLs) of the General European OMCL Network (GEON) have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) potentially present in valsartan and other sartan...

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OMCLs release three methods for determination of NDMA in sartans

EDQM 21/09/2018 Strasbourg, France

Since early July 2018, OMCLs have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) in valsartan. The Network has meanwhile developed methods for the specific testing of nitrosamines in sartans on the basis different...

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Update on detection of nitrosamines in valsartan and validated testing method

EDQM 14/09/2018 Strasbourg, France

The EDQM continues investigating and defining actions to address the presence of all kinds of nitrosamines, including NDMA and NDEA in valsartan and other sartans which may be affected. As mentioned in a previous press release, the EDQM has contacted those manufacturers holding CEPs (Certificates...

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EDQM’s actions to evaluate impact of impurity in active substance valsartan

EDQM 27/07/2018 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is aware of a quality defect related to an impurity in the active substance valsartan used in medicines to treat high blood pressure marketed in Europe. Earlier this month, a pan-European alert system has been triggered by...

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