C-237/22 PMylan IRE Healthcare Ltd v European Commission

Domstolens egne nøkkelord

Appeal – Regulation (EC) No 141/2000 – Orphan medicinal products – Articles 3 and 8 – Concept of ‘significant benefit’ – Concept of ‘clinical superiority’ – Regulation (EC) No 847/2000 – Article 3 – Marketing authorisation for the medicinal product for human use Tobramycin VVB – Period of market exclusivity of Tobi Podhaler, containing the active substance tobramycin – Derogation from that market exclusivity.

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