EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP):
- CEP 2005-076-Rev 01/Chlorhexidine digluconate solution
- CEP 2010-209-Rev 00/Calcium dobesilate monohydrate
The manufacturer concerned is:
Bajaj Healthcare Limited
Unit 11
Block No. 588, Savli-Karachia Road
Tal. Savli, Dist. Vadodara
India-391 776 Gothada, Gujarat
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.
