Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Levitra   
Auth. number : EU/1/03/248
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 Levitra 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
10/03/2003 Centralised - Authorisation EMEA/H/C/475 (2003)771 of 06/03/2003
29/01/2004 Centralised - Variation EMEA/H/C/475/II/1 (2004)231 of 27/01/2004
04/03/2004 Centralised - Variation EMEA/H/C/475/II/2, 4 (2004)733 of 02/03/2004
07/06/2004 Centralised - Variation EMEA/H/C/475/II/4, 5 (2004)2015 of 01/06/2004
31/03/2005 Centralised - Variation EMEA/H/C/475/IA/9
31/03/2005 Centralised - Variation EMEA/H/C/475/II/7 (2005)1056 of 29/03/2005
13/06/2005 Centralised - Variation EMEA/H/C/475/IA/11
Updated with Decision(2005)3227 of 16/08/2005
18/08/2005 Centralised - Variation EMEA/H/C/475/II/10 (2005)3227 of 16/08/2005
18/11/2005 Centralised - Variation EMEA/H/C/475/II/12 (2005)4506 of 15/11/2005
29/03/2006 Centralised - Variation EMEA/H/C/475/II/13
03/05/2006 Centralised - Variation EMEA/H/C/475/II/14
11/05/2006 Centralised - Variation EMEA/H/C/475/II/15 (2006)1958 of 05/05/2006
16/06/2006 Centralised - Variation EMEA/H/C/475/II/16 (2006)2368 of 12/06/2006
02/08/2006 Centralised - Variation EMEA/H/C/475/II/17 (2006)3532 of 28/07/2006
28/11/2006 Centralised - Variation EMEA/H/C/475/II/18 (2006)5871 of 24/11/2006
29/05/2007 Centralised - Variation EMEA/H/C/475/II/19
23/11/2007 Centralised - Variation EMEA/H/C/475/II/20 (2007)5786 of 21/11/2007
11/02/2008 Centralised - Renewal EMEA/H/C/475/R/21 (2008)558 of 07/02/2008
19/03/2008 Centralised - Variation EMEA/H/C/475/II/22 (2008)1138 of 17/03/2008
30/07/2008 Centralised - Variation EMEA/H/C/475/II/23, 24 (2008)4115 of 28/07/2008
27/02/2009 Centralised - Variation EMEA/H/C/475/II/25 (2009)1382 of 25/02/2009
03/06/2009 Centralised - Variation EMEA/H/C/475/IA/27
Updated with Decision(2009)5130 of 22/06/2009
25/06/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/475/T/26 (2009)5130 of 22/06/2009
06/09/2010 Centralised - Variation EMEA/H/C/475/X/28 (2010)6140 of 01/09/2010
26/10/2010 Centralised - Variation EMEA/H/C/475/IA/29
03/12/2010 Centralised - Variation EMEA/H/C/475/IB/30/G
Updated with Decision(2011)2092 of 24/03/2011
10/01/2011 Centralised - Variation EMEA/H/C/475//IA/32/G
Updated with Decision(2011)2092 of 24/03/2011
19/01/2011 Centralised - Variation EMEA/H/C/475/IB/31
Updated with Decision(2011)2092 of 24/03/2011
17/02/2011 Centralised - Variation EMEA/H/C/475/WS/108
17/02/2011 Centralised - Variation EMEA/H/C/475/WS/89
02/03/2011 Centralised - Variation EMEA/H/C/475/IG/49/G
30/03/2011 Centralised - Variation (2011)2092 of 24/03/2011
19/04/2011 Centralised - Variation EMEA/H/C/475/IB/33/G
Updated with Decision(2011)8235 of 10/11/2011
27/04/2011 Centralised - Variation EMEA/H/C/475/WS/107 (2011)2939 of 20/04/2011
31/05/2011 Centralised - Variation EMEA/H/C/475/N/35
Updated with Decision(2011)8235 of 10/11/2011
19/08/2011 Centralised - Variation EMEA/H/C/475/IA/36/G
Updated with Decision(2011)8235 of 10/11/2011
15/11/2011 Centralised - Variation (2011)8235 of 10/11/2011
23/02/2012 Centralised - Variation EMEA/H/C/475/WS/207 (2012)1271 of 21/02/2012
21/03/2012 Centralised - Variation EMEA/H/C/475/II/43 (2012)1918 of 19/03/2012
23/01/2013 Centralised - Variation EMEA/H/C/475/WS/313 (2013)360 of 21/01/2013
09/01/2014 Centralised - Variation EMEA/H/C/475/N/50
09/04/2014 Centralised - Variation EMEA/H/C/475/IB/51