EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP):
- R1-CEP 2003-156-Rev 00 / Caffeine
- R0-CEP 2006-087-Rev 01/ Theophylline
- R0-CEP 2007-345-Rev 01 / Theophylline-ethylenediamine anhydrous
- R0-CEP 2009-033-Rev 00 / Diprophylline
- R0-CEP 2010-168-Rev 00 / Theobromine
The manufacturer concerned is:
CSPC Innovation Pharmaceutical Co., Ltd.
No. 36 Fuqiang Western Road
Luangcheng County
CN-051 430 Shijiazhuang City
Hebei Province
China
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.
