Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Macugen   
Auth. number : EU/1/05/325
INN : pegaptanib sodium
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01L - Ocular vascular disorder agents
Chemical subgroup: S01LA - Antineovascularisation agents
Chemical substance: S01LA03 - Pegaptanib
(See WHO ATC Index)
Indication: treatment of neovascular (wet) age-related macular degeneration (AMD)
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
02/02/2006 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/620 (2006)304 of 31/01/2006
02/02/2006 Centralised - Authorisation EMEA/H/C/620 (2006)305 of 31/01/2006
06/10/2006 Centralised - Variation EMEA/H/C/620/IA/5
Updated with Decision(2007)1896 of 24/04/2007
27/10/2006 Centralised - Variation EMEA/H/C/620/IA/6
01/03/2007 Centralised - Variation EMEA/H/C/620/IA/9
Updated with Decision(2007)1896 of 24/04/2007
09/03/2007 Centralised - Variation EMEA/H/C/620/N/8
Updated with Decision(2007)1896 of 24/04/2007
04/04/2007 Centralised - Variation EMEA/H/C/620/IA/10
04/04/2007 Centralised - Variation EMEA/H/C/620/IA/14
04/04/2007 Centralised - Variation EMEA/H/C/620/IA/15
04/04/2007 Centralised - Variation EMEA/H/C/620/IA/13
04/04/2007 Centralised - Variation EMEA/H/C/620/IA/12
04/04/2007 Centralised - Variation EMEA/H/C/620/IA/11
26/04/2007 Centralised - Variation (2007)1896 of 24/04/2007
05/11/2007 Centralised - Variation EMEA/H/C/620/IA/19
16/11/2007 Centralised - Variation EMEA/H/C/620/IA/24
29/11/2007 Centralised - Variation EMEA/H/C/620/IA/25
04/12/2007 Centralised - Variation EMEA/H/C/620/II/17 (2007)6089 of 30/11/2007
02/01/2008 Centralised - Variation EMEA/H/C/620/II/16 (2007)6868 of 21/12/2007
30/01/2008 Centralised - Variation EMEA/H/C/620/II/18 (2008)412 of 28/01/2008
05/02/2008 Centralised - Variation EMEA/H/C/620/IA/27
12/02/2008 Centralised - Variation EMEA/H/C/620/IA/28
28/02/2008 Centralised - Variation EMEA/H/C/620/IA/29
31/07/2008 Centralised - Variation EMEA/H/C/620/IA/30
31/07/2008 Centralised - Variation EMEA/H/C/620/IA/31
07/08/2008 Centralised - Variation EMEA/H/C/620/IA/32
31/03/2009 Centralised - Variation EMEA/H/C/620/N/33
Updated with Decision(2009)6044 of 24/07/2009
30/07/2009 Centralised - Variation EMEA/H/C/620/II/34 (2009)6044 of 24/07/2009
11/08/2009 Centralised - Variation EMEA/H/C/620/IB/35
26/10/2009 Centralised - Variation EMEA/H/C/620/IA/36
26/10/2009 Centralised - Variation EMEA/H/C/620/IA/37
26/10/2009 Centralised - Variation EMEA/H/C/620/IA/38
08/03/2010 Centralised - Variation EMEA/H/C/620/IB/40
17/03/2010 Centralised - Variation EMEA/H/C/620/IB/41
Updated with Decision(2010)9645 of 20/12/2010
03/05/2010 Centralised - Variation EMEA/H/C/620/II/39/G
25/05/2010 Centralised - Variation EMEA/H/C/620/IA/42
23/12/2010 Centralised - Renewal EMEA/H/C/620/R/43 (2010)9645 of 20/12/2010
25/03/2011 Centralised - Variation EMEA/H/C/620/IG/44/G
Updated with Decision(2011)4405 of 16/06/2011
21/06/2011 Centralised - Variation (2011)4405 of 16/06/2011
29/08/2012 Centralised - Variation EMEA/H/C/620/II/47 (2012)6026 of 23/08/2012
04/12/2012 Corrigendum
28/05/2013 Centralised - Variation EMEA/H/C/620/IAin/55/G
Updated with Decision(2014)3824 of 03/06/2014
27/06/2013 Centralised - Variation EMEA/H/C/620/II/54
Updated with Decision(2014)3824 of 03/06/2014
05/06/2014 Centralised - Variation (2014)3824 of 03/06/2014