Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Visudyne   
Auth. number : EU/1/00/140
INN : verteporfin
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: S01LA01 - Verteporfin
(See WHO ATC Index)
Indication: Treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularisation, or patients with subfoveal choroidal neovascularisation secondary to pathological myopia.
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, 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
31/07/2000 Centralised - Authorisation EMEA/H/C/305 (2000)2333 of 27/07/2000
19/02/2001 Centralised - Variation EMEA/H/C/305/I/3
20/02/2001 Centralised - Variation EMEA/H/C/305/I/2 (2001)243 of 16/02/2001
22/03/2001 Centralised - Variation EMEA/H/C/305/II/1 (2001)770 of 20/03/2001
12/09/2001 Centralised - Variation EMEA/H/C/305/I/4 (2001)2189 of 10/09/2001
13/02/2002 Centralised - Variation EMEA/H/C/305/II/7
15/02/2002 Centralised - Variation EMEA/H/C/305/I/6
28/05/2002 Centralised - Variation EMEA/H/C/305/II/8 (2002)2023 of 24/05/2002
27/08/2002 Centralised - Variation EMEA/H/C/305/II/5 (2002)3182 of 22/08/2002
24/09/2002 Centralised - Variation EMEA/H/C/305/I/10
27/11/2002 Centralised - Variation EMEA/H/C/305/II/12
17/01/2003 Centralised - Variation EMEA/H/C/305/I/13 (2003)311 of 14/01/2003
24/09/2003 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/305/T/14 (2003)3425 of 22/09/2003
16/01/2004 Centralised - Variation EMEA/H/C/305/N/16 (2004)94 of 14/01/2004
10/03/2004 Centralised - Variation EMEA/H/C/305/IA/17, 18, 19
16/04/2004 Centralised - Variation EMEA/H/C/305/IA/21
19/05/2004 Centralised - Variation EMEA/H/C/305/IB/22
19/05/2004 Centralised - Variation EMEA/H/C/305/IB/20
19/08/2004 Centralised - Variation EMEA/H/C/305/N/25
Updated with Decision(2005)243 of 26/01/2005
25/10/2004 Centralised - Variation EMEA/H/C/305/II/24
14/01/2005 Centralised - Variation EMEA/H/C/305/IB/30
31/01/2005 Centralised - Variation EMEA/H/C/305/II/28 (2005)243 of 26/01/2005
31/03/2005 Centralised - Variation EMEA/H/C/305/II/26, 27, 29 (2005)1071 of 29/03/2005
06/07/2005 Centralised - Renewal EMEA/H/C/305/R/31 (2005)2654 of 04/07/2005
22/07/2005 Centralised - Variation EMEA/H/C/305/IA/32
19/08/2005 Centralised - Variation EMEA/H/C/305/IB/33
30/09/2005 Centralised - Variation EMEA/H/C/305/N/34
Updated with Decision(2007)2493 of 05/06/2007
10/11/2005 Centralised - Variation EMEA/H/C/305/IA/38
10/11/2005 Centralised - Variation EMEA/H/C/305/IA/39
10/11/2005 Centralised - Variation EMEA/H/C/305/IA/40
10/11/2005 Centralised - Variation EMEA/H/C/305/IA/37
11/11/2005 Centralised - Variation EMEA/H/C/305/IB/35
21/12/2005 Centralised - Variation EMEA/H/C/305/IB/42
21/12/2005 Centralised - Variation EMEA/H/C/305/IB/41
22/12/2005 Centralised - Variation EMEA/H/C/305/II/36
18/01/2006 Centralised - Variation EMEA/H/C/305/IB/45
28/02/2006 Centralised - Variation EMEA/H/C/305/II/44
28/02/2006 Centralised - Variation EMEA/H/C/305/II/43
16/03/2006 Centralised - Variation EMEA/H/C/305/N/47
Updated with Decision(2007)2493 of 05/06/2007
28/03/2006 Centralised - Variation EMEA/H/C/305/II/46
23/10/2006 Centralised - Variation EMEA/H/C/305/II/49
07/12/2006 Centralised - Variation EMEA/H/C/305/IB/51
12/12/2006 Centralised - Variation EMEA/H/C/305/IB/50
19/02/2007 Centralised - Variation EMEA/H/C/305/II/52
24/04/2007 Centralised - Variation EMEA/H/C/305/IA/54
Updated with Decision(2007)2493 of 05/06/2007
07/06/2007 Centralised - Variation EMEA/H/C/305/II/53 (2007)2493 of 05/06/2007
17/08/2007 Centralised - Variation EMEA/H/C/305/IA/56
17/08/2007 Centralised - Variation EMEA/H/C/305/IA/55
11/12/2007 Centralised - Variation EMEA/H/C/305/IA/57
19/03/2008 Centralised - Variation EMEA/H/C/305/II/60 (2008)1135 of 17/03/2008
25/04/2008 Centralised - Variation EMEA/H/C/305/II/58, 59 (2008)1703 of 23/04/2008
08/05/2008 Centralised - Variation EMEA/H/C/305/IA/61
18/08/2008 Centralised - Variation EMEA/H/C/305/IA/63
09/12/2008 Centralised - Variation EMEA/H/C/305/II/62 (2008)8164 of 04/12/2008
10/11/2009 Centralised - Variation EMEA/H/C/305/II/IA/65
03/12/2009 Centralised - Variation EMEA/H/C/305/IB/68
03/12/2009 Centralised - Variation EMEA/H/C/305/IB/67
09/12/2009 Centralised - Variation EMEA/H/C/305/IA/66
16/12/2009 Centralised - Variation EMEA/H/C/305/IB/64
25/03/2010 Centralised - Variation EMEA/H/C/305/II/70 (2010)2021 of 23/03/2010
07/05/2010 Centralised - Renewal EMEA/H/C/305/R/69 (2010)3070 of 05/05/2010
08/12/2010 Centralised - Variation EMEA/H/C/305/IA/71/G
13/01/2011 Centralised - Variation EMEA/H/C/305/IG/32
Updated with Decision(2011)1793 of 14/03/2011
21/03/2011 Centralised - Variation (2011)1793 of 14/03/2011
19/04/2011 Centralised - Variation EMEA/H/C/305/II/72/G
19/05/2011 Centralised - Variation EMEA/H/C/305/IG/65
10/08/2011 Centralised - Variation EMEA/H/C/305/IA/74/G
Updated with Decision(2012)1269 of 21/02/2012
23/02/2012 Centralised - Variation (2012)1269 of 21/02/2012
26/10/2012 Centralised - Variation EMEA/H/C/305/II/79 (2012)7622 of 23/10/2012
13/12/2013 Centralised - Variation EMEA/H/C/305/N/83