EN EN EUROPEAN COMMISSION Bruxelles, 29.1.2016 C(2016)679 (final) COMMISSION IMPLEMENTING DECISION of 29.1.2016 concerning the transfer of the designation of "Chimeric monoclonal antibody to O-acetyl-GD2 antigen" 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 FRENCH TEXT IS AUTHENTIC) Schedule your 30 min Free 1stOncology Demo! EN 1 EN COMMISSION IMPLEMENTING DECISION of 29.1.2016 concerning the transfer of the designation of "Chimeric monoclonal antibody to O-acetyl-GD2 antigen" 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 FRENCH 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 products 1, and in particular the first sentence of Article 5(8) thereof, Having regard to the application submitted on 11 January 2016 by Atlab Pharma SAS under Article 5(11) of Regulation (EC) No 141/2000, Having regard to the opinion of the European Medicines Agency, formulated on 12 January 2016 on the transfer of a marketing authorisation, Whereas: (1) By Decision C(2015)180(final) of 15 January 2015 the medicinal product "Chimeric monoclonal antibody to O-acetyl-GD2 antigen" was designated as an orphan medicinal product and entered in the Community Register of Orphan Medicinal Products pursuant to Article 5(9) of Regulation (EC) No 141/2000. (2) A change of designation holder is a change of an administrative nature, which does not affect the scientific characteristics of the medicinal product already designated as an orphan medicinal product. (3) The application should therefore be granted, HAS ADOPTED THIS DECISION: Article 1 The designation of the medicinal product "Chimeric monoclonal antibody to O-acetyl-GD2 antigen" as an orphan medicinal product, entered in the Community Register of Orphan Medicinal Products under number EU/3/14/1416 and held by Atlab Pharma SAS, is transferred to OGD2 Pharma. 1 OJ L 18, 22.1.2000, p.1. EN 2 EN Article 2 This Decision is addressed to: 1. OGD2 Pharma, 3 chemin du Pressoir Chênaie, 44100 Nantes, France and 2. Atlab Pharma SAS, 3 chemin du Pressoir Chênaie, 44100 Nantes, France. Done at Brussels, 29.1.2016 For the Commission Xavier PRATS MONNÉ Director-General
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