fixed combination application (article 13b of directive no 2001/82/EC)
- Guideline or reference source
- SPOR Referentials Management System of European Medicines Agency
- Definition
- Fixed combination application for veterinary use. The principles applicable to fixed combination products will also be applied in the assessment of preparations, consisting of different medicinal products in combination packs, in which the components of the combination pack are intended for simultaneous or sequential administration and for one therapeutic purpose.
- Used For
- article 13b fixed combination
- Broader Term
- application legal basis
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