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OALib Journal期刊
ISSN: 2333-9721
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Generic clopidogrel–the medicines agency’s perspective

Keywords: bioequivalence , clopidogrel , drug substitution , drugs , generics , therapeutic equivalency

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Abstract:

A number of generic products containing clopidogrel as the active substance have been marketed in Austria and the EU for some time. Due to diff erent clopidogrel salt preparations and diff erent indications, doubts arose as to whether the products could be considered as equivalent. The Austrian Federal Office for Safety in Health Care (BASG)/The Austrian Agency for Health and Food Safety (AGES PharmMed) considered this issue and reached the conclusion that the generic clopidogrel products were in principle equivalent to the originator product with regard to safety and efficacy.

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