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