Judgment of the General Court (Second Chamber) of 5 December 2018.#Bristol-Myers Squibb Pharma EEIG v European Commission and European Medicines Agency.#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 (Second Chamber) of 5 December 2018.
Bristol-Myers Squibb Pharma EEIG v European Commission and European Medicines Agency.
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 (Second Chamber) of 5 December 2018.
Bristol-Myers Squibb Pharma EEIG v European Commission and European Medicines Agency.
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.

ECLI identifier: ECLI:EU:T:2018:878