EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP):
- CEP 2005-277 / Mesalazine
The manufacturer concerned is:
Jiangsu Tianhe Pharmaceutical Ltd.
Nº 176 Kunlun Nan Road
213300 Liyang
China
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.
You can find more information at the EDQM's website via the box to the right.
