Suspension of Certificate of Suitability for the active substance Leflunomide

EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP):

• CEP 2009-035/Leflunomide

The manufacturer concerned is:

Formosa Laboratories Inc.
No. 36 Hoping Street, Louchu County
Taoyuan
33842 Taiwan

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.