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`COMMISSION OF THE EUROPEAN COMMUNITIES
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`Brussels, 05-IX-2005
`C(2005)3436
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`NOT FOR PUBLICATION
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`COMMISSION DECISION
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`of 05-IX-2005
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`amending the marketing authorisation for "Ventavis - Iloprost", a medicinal
`product for human use, granted by Decision C(2003)3348
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`ONLY THE GERMAN TEXT IS AUTHENTIC
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`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1042, p. 1 of 4
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` COMMISSION DECISION
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`of 05-IX-2005
`
`amending the marketing authorisation for "Ventavis - Iloprost", a medicinal
`product for human use, granted by Decision C(2003)3348
`
`(Text with EEA relevance)
`
`THE COMMISSION OF THE EUROPEAN COMMUNITIES,
`
`Having regard to the Treaty establishing the European Community,
`
`Having regard to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down
`Community procedures for the authorisation and supervision of medicinal products for
`human and veterinary use and establishing a European Agency for the Evaluation of
`Medicinal Products1,
`
`Having regard to Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning
`the examination of variations to the terms of a marketing authorisation for medicinal
`products for human use and veterinary medicinal products falling within the scope of
`Council Regulation (EEC) No 2309/932, and in particular the first subparagraph of
`Article 6(10) thereof,
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`Having regard to the application submitted by Schering AG on 14 January 2005 under
`Article 6(1) of Commission Regulation (EC) No 1085/2003,
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`Having regard to 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 use3,
`and in particular Article 61(3) thereof,
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`Having regard to the opinion of the European Medicines Agency, formulated by the
`Committee for Medicinal Products for Human Use on 27 July 2005,
`
`Whereas:
`
`(1)
`
`An examination of the major variation type II to the terms of the marketing
`authorisation for the medicinal product "Ventavis - Iloprost", which is entered in
`the Community Register of Medicinal Products under No(s) EU/1/03/255/001-
`003 and the placing on the market of which was authorised by Decision
`
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`1 OJ L 214, 24.8.1993, p. 1. Regulation as last amended by [Regulation (EC) No 1647/2003 (OJ L 245,
`29.9.2003, p. 19)].
`2 OJ L 159, 27.6.2003, p. 24.
`3 OJ L 311, 28.11.2001, p. 67. Directive as last amended by [Directive 2004/27/EC (OJ L 136, 30.4.2004,
`p. 34).]
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`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1042, p. 2 of 4
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`(2)
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`(3)
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`(4)
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`(5)
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`C(2003)3348 of 16 September 2003, has shown that the product remains in
`compliance 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 use4.
`
`It is therefore appropriate to accept the application in respect of a major variation
`to the terms of the marketing authorisation and to amend Decision C(2003)3348
`accordingly.
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`During the same period, Schering AG submitted, under Article 61(3) of Directive
`2001/83/EC, a notification(s) for changes to an aspect of the labelling or the
`package leaflet. The competent authority did not oppose the proposed change
`within the 90-day time-limit.
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`The marketing authorisation should be updated, and Decision C(2003)3348
`amended accordingly.
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`For the sake of clarity and transparency, it is advisable, following the amendment
`of part or parts of the Annexes, to provide for a consolidated version thereof. The
`Annexes to Decision C (2003)3348 should therefore be replaced,
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`HAS ADOPTED THIS DECISION:
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`Decision C(2003)3348 is amended as follows:
`
`Article 1
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`1) The list of notifications for changes to an aspect of the labelling or the package leaflet,
`accepted between 19 November 2004 and 27 July 2005, is added to the updated
`marketing authorisation;
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`Application number
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`Annex (EU numbers affected)
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`EMEA/H/C/000474/N/0004 IIIAB (EU/1/03/255/001-003)
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`2) Annex I is replaced by the text set out in Annex I to this Decision;
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`3) Annex III is replaced by the text set out in Annex III to this Decision.
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`4 OJ L 311, 28.11.2001, p. 67. Directive as last amended by [Directive 2004/27/EC (OJ L 136, 30.4.2004,
`p.34)].
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`Article 2
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`This Decision is addressed to Schering AG, Müllerstrasse 170-178, D - 13342 Berlin,
`Deutschland.
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`Done at Brussels, 05-IX-2005
`
`For the Commission
`Günter VERHEUGEN
`Member of the Commission
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