Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Viagra   
Auth. number : EU/1/98/077
Active substance : sildenafil
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: G04BE03 - Sildenafil
(See WHO ATC Index)
Indication: indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.In order for VIAGRA to be effective, sexual stimulation is required.
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
15/09/1998 Centralised - Authorisation EMEA/H/C/202 (1998)2645 of 14/09/1998
16/08/1999 Centralised - Variation EMEA/H/C/202/II/1 (1999)2673 of 09/08/1999
22/09/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/I/2
15/12/1999 Centralised - Variation EMEA/H/C/202/I/3 (1999)4331 of 14/12/1999
14/02/2000 Centralised - Variation EMEA/H/C/202/II/4 (2000)314 of 10/02/2000
27/04/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/I/5
13/09/2000 Centralised - Variation EMEA/H/C/202/II/6 (2000)2557 of 12/09/2000
28/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/I/7
28/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/I/9
15/12/2000 Centralised - Variation EMEA/H/C/202/I/8 (2000)3478 of 07/12/2000
22/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/I/10
29/11/2001 Centralised - Variation EMEA/H/C/202/II/11 (2001)3862 of 27/11/2001
07/03/2002 Centralised - Variation EMEA/H/C/202/I/12 (2002)972 of 05/03/2002
22/04/2002 Centralised - Variation EMEA/H/C/202/II/13 (2002)1547 of 18/04/2002
29/10/2002 Centralised - Variation EMEA/H/C/202/I/15 (2002)4300 of 24/10/2002
09/12/2002 Centralised - Notification EMEA/H/C/202/N/16 (2002)4958 of 04/12/2002
11/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/I/17
31/07/2003 Centralised - Variation EMEA/H/C/202/II/18 (2003)2837 of 29/07/2003
13/11/2003 Centralised - Renewal EMEA/H/C/202/R/19 (2003)4286 of 11/11/2003
23/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IB/21
02/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IB/22
01/06/2004 Centralised - Variation EMEA/H/C/202/II/20 (2004)1980 of 26/05/2004
20/08/2004 Centralised - Variation EMEA/H/C/202/IA/23
Updated with Decision(2005)1063 of 29/03/2005
31/03/2005 Centralised - Variation (2005)1063 of 29/03/2005
29/04/2005 Centralised - Variation EMEA/H/C/202/II/24 (2005)1378 of 27/04/2005
18/11/2005 Centralised - Variation EMEA/H/C/202/II/25 (2005)4484 of 15/11/2005
12/06/2006 Centralised - Variation EMEA/H/C/202/II/26 (2006)2305 of 08/06/2006
21/12/2006 Centralised - Notification EMEA/H/C/202/N/27
Updated with Decision(2008)1147 of 17/03/2008
16/02/2007 Centralised - Notification EMEA/H/C/202/N/28
Updated with Decision(2008)1147 of 17/03/2008
27/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IB/29
05/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IA/30
19/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IA/31
19/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IA/32
19/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IA/33
12/10/2007 Centralised - Variation EMEA/H/C/202/IA/36
Updated with Decision(2008)1147 of 17/03/2008
12/10/2007 Centralised - Variation EMEA/H/C/202/IA/37
Updated with Decision(2008)1147 of 17/03/2008
12/10/2007 Centralised - Variation EMEA/H/C/202/IA/38
Updated with Decision(2008)1147 of 17/03/2008
15/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IA/39
16/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IA/40
12/11/2007 Centralised - Notification EMEA/H/C/202/N/35
Updated with Decision(2008)1147 of 17/03/2008
13/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IB/41
02/12/2007 Centralised - Variation EMEA/H/C/202/IA/46
Updated with Decision(2008)1147 of 17/03/2008
02/12/2007 Centralised - Variation EMEA/H/C/202/IA/47
Updated with Decision(2008)1147 of 17/03/2008
02/12/2007 Centralised - Variation EMEA/H/C/202/IA/48
Updated with Decision(2008)1147 of 17/03/2008
16/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IA/49
16/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IA/50
19/03/2008 Centralised - Variation EMEA/H/C/202/II/51 (2008)1147 of 17/03/2008
01/04/2008 Centralised - Variation EMEA/H/C/202/IA/53
Updated with Decision(2008)4704 of 26/08/2008
01/04/2008 Centralised - Variation EMEA/H/C/202/IA/54
Updated with Decision(2008)4704 of 26/08/2008
01/04/2008 Centralised - Variation EMEA/H/C/202/IA/55
Updated with Decision(2008)4704 of 26/08/2008
01/04/2008 Centralised - Variation EMEA/H/C/202/IA/56
Updated with Decision(2008)4704 of 26/08/2008
28/08/2008 Centralised - Renewal EMEA/H/C/202/R/52 (2008)4704 of 26/08/2008
30/01/2009 Centralised - Notification EMEA/H/C/202/N/57
Updated with Decision(2010)4664 of 01/07/2010
15/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IB/202
07/08/2009 Centralised - Notification EMEA/H/C/202/N/59
Updated with Decision(2010)4664 of 01/07/2010
21/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IA/62
25/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/II/63
07/06/2010 Centralised - Variation (refusal) EMEA/H/C/202/IA/66
14/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IA/65
05/07/2010 Centralised - Variation EMEA/H/C/202/II/64 (2010)4664 of 01/07/2010
11/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IB/67
07/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IB/68
07/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/202/IA/69/G
13/12/2012 Centralised - Variation EMEA/H/C/202/II/73
Updated with Decision(2013)2306 of 17/04/2013
19/04/2013 Centralised - Variation EMEA/H/C/202/X/70 (2013)2306 of 17/04/2013
25/07/2013 Centralised - Variation EMEA/H/C/202/II/78
Updated with Decision(2014)5111 of 14/07/2014
23/01/2014 Centralised - Variation EMEA/H/C/202/II/79, 80
Updated with Decision(2014)5111 of 14/07/2014
20/03/2014 Centralised - Variation EMEA/H/C/202/II/82
Updated with Decision(2014)5111 of 14/07/2014
16/07/2014 Centralised - Yearly update (2014)5111 of 14/07/2014
20/08/2014 Centralised - Notification EMEA/H/C/202/N/84
Updated with Decision(2015)6678 of 23/09/2015
23/10/2014 Centralised - Variation EMEA/H/C/202/IAin/85
Updated with Decision(2015)6678 of 23/09/2015
17/04/2015 Centralised - Variation EMEA/H/C/202/IB/87/G
Updated with Decision(2015)6678 of 23/09/2015
17/06/2015 Centralised - Variation EMEA/H/C/202/IB/89
Updated with Decision(2015)6678 of 23/09/2015
24/06/2015 Centralised - Notification EMEA/H/C/202/N/88
Updated with Decision(2015)6678 of 23/09/2015
28/09/2015 Centralised - Yearly update (2015)6678 of 23/09/2015
26/01/2016 Centralised - 2-Monthly update EMEA/H/C/202/IB/90 (2016)416 of 22/01/2016
29/01/2016 Centralised - Variation EMEA/H/C/202/IB/91
17/06/2016 Centralised - Notification EMEA/H/C/202/N/93