`COMMISSION
`
`Brussels, 17.6.2021
`C(2021) 4584 final
`
`COMMISSION IMPLEMENTING DECISION
`
`of 17.6.2021
`
`granting marketing authorisation under Regulation (EC) No 726/2004 of the European
`Parliament and of the Council for "Onureg - azacitidine", a medicinal product for
`human use
`
`(Text with EEA relevance)
`
`(ONLY THE ENGLISH TEXT IS AUTHENTIC)
`
`EN
`
`(cid:38)(cid:40)(cid:47)(cid:42)(cid:40)(cid:49)(cid:40)(cid:3)(cid:21)(cid:19)(cid:24)(cid:28)
`(cid:36)(cid:51)(cid:50)(cid:55)(cid:40)(cid:59)(cid:3)(cid:89)(cid:17)(cid:3)(cid:38)(cid:40)(cid:47)(cid:42)(cid:40)(cid:49)(cid:40)
`(cid:44)(cid:51)(cid:53)(cid:21)(cid:19)(cid:21)(cid:22)(cid:16)(cid:19)(cid:19)(cid:24)(cid:20)(cid:21)
`
`EN
`
`
`
`
`
`COMMISSION IMPLEMENTING DECISION
`
`of 17.6.2021
`
`granting marketing authorisation under Regulation (EC) No 726/2004 of the European
`Parliament and of the Council for "Onureg - azacitidine", a medicinal product for
`human use
`
`(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 726/2004 of the European Parliament and of the
`Council of 31 March 2004 laying down Community procedures for the authorisation and
`supervision of medicinal products for human and veterinary use and establishing a European
`Medicines Agency1, and in particular Article 10(2) thereof,
`Having regard to the application submitted by Bristol-Myers Squibb Pharma EEIG, on 21
`May 2020, under Article 4(1) of Regulation (EC) No 726/2004,
`Having regard to the opinion of the European Medicines Agency, formulated on 22 April
`2021 by the Committee for Medicinal Products for Human Use,
`Whereas:
`(1)
`The medicinal product "Onureg - azacitidine" complies with the requirements set out
`in Directive 2001/83/EC of the European Parliament and of the Council of 6
`November 2001 on the Community code relating to medicinal products for human
`use2.
`It is therefore appropriate to authorise its placing on the market.
`The measures provided for in this Decision are in accordance with the opinion of the
`Standing Committee on Medicinal Products for Human Use,
`HAS ADOPTED THIS DECISION:
`
`(2)
`(3)
`
`Article 1
`The marketing authorisation provided for in Article 3 of Regulation (EC) No 726/2004 is
`granted for the medicinal product "Onureg - azacitidine", the characteristics of which are
`summarised in Annex I to this Decision. "Onureg - azacitidine" shall be registered in the
`Union Register of Medicinal Products under number EU/1/21/1556.
`
`1
`2
`
`OJ L 136, 30.4.2004, p. 1.
`OJ L 311, 28.11.2001, p. 67.
`
`EN
`
`1
`
` EN
`
`
`
`
`
`Article 2
`The marketing authorisation concerning the medicinal product referred to in Article 1 shall be
`subject to compliance with the conditions set out in Annex II and, in particular, with those
`relating to manufacture and importation, control and issue.
`
`Article 3
`The labelling and package leaflet concerning the medicinal product referred to in Article 1
`shall comply with the conditions set out in Annex III.
`
`Article 4
`The period of validity of the authorisation shall be five years from the date of notification of
`this Decision.
`
`Article 5
`to Bristol-Myers Squibb Pharma EEIG, Plaza 254,
`is addressed
`This Decision
`Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland.
`Done at Brussels, 17.6.2021
`
`For the Commission
`Sandra GALLINA
`Director-General
`
`
`
`
`
`
`
`
`
`EN
`
`2
`
` EN
`
`
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