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Case T-329/16: Judgment of the General Court of 5 December 2018 — Bristol-Myers Squibb Pharma v Commission and EMA (Medicinal products for human use — Orphan medicinal products — Decision withdrawing the designation of Elotuzumab as an orphan medicinal product — Decision that the designation criteria were no longer met — Marketing authorisation for the medicinal product for human use Empliciti (Elotuzumab) — Article 5(12)(b) of Regulation (EC) No 141/2000 — Article 5(8) of Regulation No 141/2000 — Obligation to state reasons)
Case T-329/16: Judgment of the General Court of 5 December 2018 — Bristol-Myers Squibb Pharma v Commission and EMA (Medicinal products for human use — Orphan medicinal products — Decision withdrawing the designation of Elotuzumab as an orphan medicinal product — Decision that the designation criteria were no longer met — Marketing authorisation for the medicinal product for human use Empliciti (Elotuzumab) — Article 5(12)(b) of Regulation (EC) No 141/2000 — Article 5(8) of Regulation No 141/2000 — Obligation to state reasons)
Publication metadata
- Published:
- Corporate author(s): General Court (Court of Justice of the European Union)
- Subject: drug surveillance , market approval , orphan disease , orphan drug
- IMMC : ARR-T-0329-2016
- CELEX : 62016TA0329
- OJ : JOC_2019_044_R_0025
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