fixed combination application (article 10b of directive no 2001/83/EC)
- Guideline or reference source
- SPOR Referentials Management System of European Medicines Agency
- Definition
- Fixed combination application for human use. The combination of active substances within a single pharmaceutical form of administration is a socalled ‘fixed combination’. A ‘combination pack’ consist of more than one medicinal product, or more than one pharmaceutical form of the same medicinal product, presented under a single (invented) name, where the individual products/forms are intended for simultaneous or sequential administration.
- Used For
- article 10b fixed combination application
- Broader Term
- application legal basis
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