Council for europe portal
Language : en Search
Choose language

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

Back
Certification of suitability (CEP)
API
News
27 July 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 the European Medicines Agency (EMA) in order to assess the extent of this incident and to establish remedial action plans.

The EDQM is part of this pan-European alert system and is actively working with the EMA and national competent authorities to better understand the potential impact of this impurity and the extent of the issue.

Read more about the EDQM’s actions taken

  • More information about  the certification procedure or CEPs HERE
  • More information about the European Pharmacopoeia (Ph. Eur.) HERE
twitter facebook googleplus pinterest linkedin email