- Query in any language with multilingual search
- Access EUR-Lex and EU Commission case law
- See relevant paragraphs highlighted instantly
Similar Documents
Explore similar documents to your case.We Found Similar Cases for You
Case T-223/20: Judgment of the General Court of 13 November 2024 – Orion v Commission (Medicinal products for human use – Generic medicinal products – Decision granting marketing authorisation for the medicinal product for human use Dexmedetomidine Accord – dexmedetomidine – Eligibility of a medicinal product as a reference medicinal product – Article 10(1) and (2) of Directive 2001/83/EC)
ECLI:EU:UNKNOWN:62020TA0223
62020TA0223
With us you find everything. Try it now!
I imagine what I want to write in my case, I write it in the search engine and I get exactly what I wanted. Thank you!
Valentina R., lawyer
Official Journal of the European Union
C series
—
C/2025/261
(Case T-223/20)
(Medicinal products for human use - Generic medicinal products - Decision granting marketing authorisation for the medicinal product for human use Dexmedetomidine Accord - dexmedetomidine - Eligibility of a medicinal product as a reference medicinal product - Article 10(1) and (2) of Directive 2001/83/EC)
(C/2025/261)
Language of the case: English
Parties
Applicant: Orion Oyj (Espoo, Finland) (represented by: C. Schoonderbeek, lawyer, J. Mulryne and E. Amos, Solicitors, and J. Stratford, Barrister-at-Law)
Defendant: European Commission (represented by: L. Haasbeek, E. Mathieu and R. Lindenthal, acting as Agents)
Intervener in support of the defendant: Accord Healthcare, SL (represented by: C. Drew, Solicitor, D. Piccinin, Barrister, and T. Johnston, Barrister-at-Law)
Re:
By its action under Article 263 TFEU, the applicant seeks the annulment of Commission Implementing Decision C(2020) 942 (final) of 13 February 2020 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council [of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1)] for ‘Dexmedetomidine Accord – dexmedetomidine’, a medicinal product for human use.
Operative part of the judgment
The Court:
1.Annuls Commission Implementing Decision C(2020) 942 (final) of 13 February 2020 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council [of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency] for the medicinal product for human use ‘Dexmedetomidine Accord – dexmedetomidine’;
2.Orders the European Commission to bear its own costs and to pay the costs incurred by Orion Oyj;
3.Orders Accord Healthcare, SL to bear its own costs.
—
Language of the case: English.
ELI: http://data.europa.eu/eli/C/2025/261/oj
ISSN 1977-091X (electronic edition)
—