COMMISSION IMPLEMENTING DECISION relating to the designation of "Tranilast" as an orphan medicinal product under Regulation (EC) No 141/2000 of the European Parliament and of the Council

EUROPEAN COMMISSION COMMISSION IMPLEMENTING DECISION of 22.5.2025 Brussels, 22.5.2025 C(2025) 3442 final relating to the designation of "Tranilast" as an orphan medicinal product under Regulation (EC) No 141/2000 of the European Parliament and of the Council (Text with EEA relevance) (ONLY THE ENGLISH TEXT IS AUTHENTIC) COMMISSION IMPLEMENTING DECISION of 22.5.2025 relating to the designation of "Tranilast" as an orphan medicinal product under Regulation (EC) No 141/2000 of the European Parliament and of the Council (Text with EEA relevance) (ONLY THE ENGLISH TEXT IS AUTHENTIC) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products1, and in particular the first sentence of Article 5(8) thereof, Having regard to the application submitted by Boyd Consultants Limited on 27 January 2025 under Article 5(1) of Regulation (EC) No 141/2000, Having regard to the favourable opinion of the European Medicines Agency, drawn up on 15 April 2025 by the Committee for Orphan Medicinal Products and received by the Commission on 28 April 2025, Whereas: (1) The application submitted by Boyd Consultants Limited concerning the medicinal product “Tranilast” was validated on 26 February 2025 under Article 5(4) of Regulation (EC) No 141/2000. (2) "Tranilast" meets the designation...