EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP):
CEP R1-1998-070-Rev02 Pyrazinamide
The manufacturer concerned is:
Linaria Chemicals (Thailand) Ltd.
309 Soi, 6 Pattana 3 Road
Bangpoo Industrial Estate, Preksha
TH – 10280 Samutprakarn
Thailand
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 the active substance 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 factbox to the right.
Danish Medicines Agency, 17 December 2010
