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Case T-455/24 R: Order of the President of the General Court of 26 November 2024 – Advanz Pharma v Commission (Interim relief – Medicinal products for human use – Orphan medicinal product for human use Ocaliva – obeticholic acid – Revocation of a conditional marketing authorisation – Application for suspension of operation of a measure – No urgency)

ECLI:EU:UNKNOWN:62024TB0455

62024TB0455

November 26, 2024
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Official Journal of the European Union

C series

C/2025/570

3.2.2025

(Case T-455/24 R)

(Interim relief - Medicinal products for human use - Orphan medicinal product for human use ‘Ocaliva - obeticholic acid’ - Revocation of a conditional marketing authorisation - Application for suspension of operation of a measure - No urgency)

(C/2025/570)

Language of the case: English

Parties

Applicant: Advanz Pharma Ltd (Dublin, Ireland) (represented by: J. Bourgeois and M. Meulenbelt, lawyers)

Defendant: European Commission (represented by: R. Lindenthal, A. Spina and E. Mathieu, acting as Agents)

Re:

By its application under Articles 278 and 279 TFEU, the applicant seeks suspension of the operation of Commission Implementing Decision C(2024) 6281 final of 30 August 2024 revoking, under Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, the conditional marketing authorisation, granted by Implementing Decision C(2016) 8685 final, for ‘Ocaliva – obeticholic acid’, an orphan medicinal product for human use.

Operative part of the order

1.The application for interim measures is dismissed.

2.The order of 4 September 2024, Advanz Pharma v Commission (T-455/24 R), is cancelled.

3.The costs are reserved.

ELI: http://data.europa.eu/eli/C/2025/570/oj

ISSN 1977-091X (electronic edition)

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