Generic Clopidogrel Replacement
On March 29, 2010, the delivery of generic drugs containing Clopidogrel, which used the active ingredient of the supplier Glochem Industries Ltd., was stopped for the time being on wholesale level by BASG/AGES PharmMed. It was determined that the production of the active ingredient was not carried out in compliance with GMP (Good Manufacturing Practice), and there was no health risk at any time. Nevertheless, the responsible expert committee of the EMA (CHMP) decided on the recall of centrally approved clopidogrel products in an extraordinary telephone conference on March 25, 2010, which was followed by the EU Commission on March 29, 2010. This decision is now also followed by BASG/AGES PharmMed with a replacement of the centrally approved products "Clopidogrel Sandoz" and "Clopidogrel Ratiopharm" as well as the decentrally approved products "Clogrelhexal" and "Clogombix", as the affected marketing authorization holders can provide replacement products.
In Austria, the following preparations will thus be replaced:
- Clopidogrel Sandoz 75 mg Film-Coated Tablets (Admission No. EU/1/09/547/001-007)
- Clogrelhexal 75 mg Film-Coated Tablets (Admission No. 1-28543)
- Clogombix 75 mg Film-Coated Tablets (Admission No. 1-28544)
- Clopidogrel Ratiopharm 75 mg Film-Coated Tablets (Admission No. EU/1/09/554/001-007)
Wholesalers and institutional pharmacies are requested to inform their supplied customers/sites immediately of this exchange and to replace the affected products with new batches. Replacement products contain active ingredient from an alternative, GMP-compliant source.
Information for physicians/patients
- There is no health risk. This substitution is a precautionary measure.
- The marketing authorization holders of the affected generic products have changed active ingredient suppliers so that future batches will be manufactured in compliance with GMP.
Further information:
2010-03-25, EMA press release.
03/30/2010, European Commission procedures "Clopidogrel Sandoz"
30.03.2010, European Commission procedures "Clopidogrel ratiopharm"
Queries:
Univ.-Prof. Dr. Marcus Müllner
E-mail: pr_pharmmed@ages.at
