Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vivanza   
Auth. number : EU/1/03/249
INN : Vardenafil
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G04 - Urologicals
Pharmacological subgroup: G04B - Other urologicals, including antispasmodics
Chemical subgroup: G04BE - Drugs used in erectile dysfunction
Chemical substance: G04BE09 - Vardenafil
(See WHO ATC Index)
Indication: Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
In order for Vivanza to be effective, sexual stimulation is required.
Marketing Authorisation Holder: Bayer Pharma AG
D-13342 Berlin, Deutschland

  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
06/03/2003 Centralised - Authorisation EMEA/H/C/488 (2003)755 of 04/03/2003
29/01/2004 Centralised - Variation EMEA/H/C/488/II/1 (2004)214 of 27/01/2004
04/03/2004 Centralised - Variation EMEA/H/C/488/II/2, 3, 6 (2004)747 of 02/03/2004
07/06/2004 Centralised - Variation EMEA/H/C/488/II/4,0005 (2004)2010 of 01/06/2004
09/02/2005 Centralised - Variation EMEA/H/C/488/IA/8
31/03/2005 Centralised - Variation EMEA/H/C/488/IA/9
31/03/2005 Centralised - Variation EMEA/H/C/488/II/7 (2005)1057 of 29/03/2005
13/06/2005 Centralised - Variation EMEA/H/C/488/IA/11
Updated with Decision(2005)3225 of 16/08/2005
18/08/2005 Centralised - Variation EMEA/H/C/488/II/10 (2005)3225 of 16/08/2005
18/11/2005 Centralised - Variation EMEA/H/C/488/II/12 (2005)4494 of 15/11/2005
29/03/2006 Centralised - Variation EMEA/H/C/488/II/13
03/05/2006 Centralised - Variation EMEA/H/C/488/II/14
11/05/2006 Centralised - Variation EMEA/H/C/488/II/15 (2006)1960 of 05/05/2006
16/06/2006 Centralised - Variation EMEA/H/C/488/II/16 (2006)2365 of 12/06/2006
02/08/2006 Centralised - Variation EMEA/H/C/488/II/17 (2006)3531 of 28/07/2006
28/11/2006 Centralised - Variation EMEA/H/C/488/II/18 (2006)5872 of 24/11/2006
29/05/2007 Centralised - Variation EMEA/H/C/488/II/19
22/11/2007 Centralised - Variation EMEA/H/C/488/II/20 (2007)5702 of 20/11/2007
11/02/2008 Centralised - Renewal EMEA/H/C/488/R/21 (2008)559 of 07/02/2008
19/03/2008 Centralised - Variation EMEA/H/C/488/II/22 (2008)1134 of 17/03/2008
30/07/2008 Centralised - Variation EMEA/H/C/488/II/23, 24 (2008)4114 of 28/07/2008
27/02/2009 Centralised - Variation EMEA/H/C/488/II/25 (2009)1387 of 25/02/2009
03/06/2009 Centralised - Variation EMEA/H/C/488/IA/27
Updated with Decision(2009)5049 of 18/06/2009
22/06/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/488/T/26 (2009)5049 of 18/06/2009
10/01/2011 Centralised - Variation EMEA/H/C/488/IA/28/G
17/02/2011 Centralised - Variation EMEA/H/C/488/WS/89
17/02/2011 Centralised - Variation EMEA/H/C/488/WS/108
02/03/2011 Centralised - Variation EMEA/H/C/488/IG/49/G
18/04/2011 Centralised - Variation EMEA/H/C/488/IB/29/G
Updated with Decision(2011)8516 of 16/11/2011
27/04/2011 Centralised - Variation EMEA/H/C/488/WS/107 (2011)2938 of 20/04/2011
31/05/2011 Centralised - Variation EMEA/H/C/488/N/31
Updated with Decision(2011)8516 of 16/11/2011
19/08/2011 Centralised - Variation EMEA/H/C/488/IA/32/G
Updated with Decision(2011)8516 of 16/11/2011
18/11/2011 Centralised - Variation (2011)8516 of 16/11/2011
24/02/2012 Centralised - Variation EMEA/H/C/488/WS/207 (2012)1272 of 21/02/2012
12/06/2012 Centralised - Variation EMEA/H/C/488/N/39
Updated with Decision(2013)361 of 21/01/2013
23/01/2013 Centralised - Variation EMEA/H/C/488/WS/313 (2013)361 of 21/01/2013
01/07/2013 Centralised - Variation EMEA/H/C/488/X/43 (2013)4188 of 27/06/2013
09/01/2014 Centralised - Variation EMEA/H/C/488/N/46
06/05/2014 Centralised - Variation EMEA/H/C/488/N/47