EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP):
- RO-CEP 2007-245-Rev 01 Trimetazidine dihydrochloride
The manufacturer concerned is:
ANEK Prayog PVT LTD; 57/2 MIDC IND
Aera Dhatav; Raigad District, Roha,
Maharashtra, 402 116, India
If the EDQM withdraws or suspends a CEP, the marketing authorisation holder must take the necessary measures to ensure that active substances from the concerned active substance manufacturer are not used, either permanently or for a defined period.
If any medicines on the market contain these active substances from the concerned active substance manufacturers, the marketing authorisation holder must report the product defect to the Danish Health and Medicines Authority at rapidalert@dkma.dk.
Please find additional information on EDQM's website.
