EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP):
- R1-CEP 2001-278-Rev 02 / buprenorphine hydrochloride
- R0-CEP 2005-164-Rev 00 / fentanyl
- R0-CEP 2007-065-Rev 00 / buprenorphine
- R0-CEP 2008-167-Rev 00 / naltrexone hydrochloride
The manufacturer concerned is:
Rusan Pharma Ltd
Plot No 6406, G.I.D.C.
Near Hoechst Chokad, Dist. Bharuch
India-393 002 Anklshwar, Gujarati
If the EDQM withdraws or suspends a Certificate of Suitability (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 manufacturer, the marketing authorisation holder must report the product defect to the Danish Medicines Agency at rapidalert@dkma.dk.
Please find addotional information on EDQM´s website.
