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Update on EDQM’s actions following detection of impurity in valsartan

30/08/2018 Strasbourg, France

The EDQM is continuing the investigations and actions which started in July 2018 to address the issue related to the detection of a nitrosamine (N-nitrosodimethylamine (NDMA)) in a source of active substance valsartan.

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

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. Traces of the impurity N-nitrosodimethylamine (NDMA), a...

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Outcome of the 161st Session of the European Pharmacopoeia Commission

29/06/2018 Strasbourg, France

At its 161st Session, which took place in Strasbourg on 19-20 June 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 10 new monographs, 1 new chapter, 92 revised monographs and 7 revised chapters.

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EN FR

EDQM publishes a new section dedicated to biotherapeutics on its website

29/06/2018 Strasbourg, France

The new biotherapeutics section on the EDQM website summarises Ph. Eur. Commission activities and achievements in this field. In addition to clarification of the role of Ph. Eur. monographs in the biosimilars regulatory pathway, it describes the recently concluded P4-BIO pilot phase and the...

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EN FR

EDQM/European Pharmacopeia: new building will ensure continuity in pharmaceutical reference standards supply

11/06/2018 Metz, France

The first stone of the new secondary site of the Council of Europe’s European Directorate for the Quality of Medicines and HealthCare (EDQM) was laid today. The new site will be used to store its portfolio of over 3 000 pharmaceutical reference standards, as an addition to those already in...

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