EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificate of Suitability (CEP):
- R0-CEP 2005-158-Rev 00 / Oxaliplatin.
The manufacturer concerned is:
Desynth SA.
Rivera Indarte 327
C1406DXG Ciudad Autonoma De Buenos Aires, Argentina
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 this active substance from the concerned active substance manufacturer, 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.
