Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Revatio   
Auth. number : EU/1/05/318
INN : sildenafil
Orphan status based on designation EU/3/03/178 added on 04/11/2005
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: Adults
Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.

Paediatric population
Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.
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
04/11/2005 Centralised - Authorisation EMEA/H/C/638 (2005)4326 of 28/10/2005
20/06/2006 Centralised - Variation EMEA/H/C/638/II/1 (2006)2444 of 16/06/2006
01/09/2006 Centralised - Variation EMEA/H/C/638/II/2 (2006)3958 of 28/08/2006
09/10/2006 Centralised - Variation EMEA/H/C/638/N/4
Updated with Decision(2007)180 of 17/01/2007
19/01/2007 Centralised - Variation EMEA/H/C/638/II/3 (2007)180 of 17/01/2007
04/04/2007 Centralised - Variation EMEA/H/C/638/II/6 (2007)1539 of 29/03/2007
17/04/2007 Centralised - Annual reassessment EMEA/H/C/638/S/5 (2007)1774 of 13/04/2007
05/07/2007 Centralised - Variation EMEA/H/C/638/IA/8
16/09/2007 Centralised - Variation EMEA/H/C/638/N/9
Updated with Decision(2008)1143 of 17/03/2008
19/09/2007 Centralised - Variation EMEA/H/C/638/IA/11
19/09/2007 Centralised - Variation EMEA/H/C/638/IA/10
19/09/2007 Centralised - Variation EMEA/H/C/638/IA/12
13/11/2007 Centralised - Variation EMEA/H/C/638/IB/15
29/02/2008 Centralised - Variation EMEA/H/C/638/N/7
Updated with Decision(2008)1143 of 17/03/2008
19/03/2008 Centralised - Variation EMEA/H/C/638/II/16 (2008)1143 of 17/03/2008
27/08/2008 Centralised - Annual reassessment EMEA/H/C/638/S/17 (2008)4671 of 25/08/2008
30/10/2008 Centralised - Variation EMEA/H/C/638/II/18 (2008)6488 of 28/10/2008
13/02/2009 Centralised - Variation EMEA/H/C/638/N/20
Updated with Decision(2009)5605 of 07/07/2009
05/03/2009 Centralised - Variation EMEA/H/C/638/IA/22
05/05/2009 Centralised - Variation EMEA/H/C/638/IA/24
05/05/2009 Centralised - Variation EMEA/H/C/638/IA/25
28/05/2009 Centralised - Variation EMEA/H/C/638/IB/26
09/07/2009 Centralised - Variation EMEA/H/C/638/II/21 (2009)5605 of 07/07/2009
05/08/2009 Centralised - Variation EMEA/H/C/638/II/23 (2009)6253 of 03/08/2009
22/12/2009 Centralised - Variation EMEA/H/C/638/X/19 (2009)10688 of 21/12/2009
24/12/2009 Centralised - Variation EMEA/H/C/638/X/19 (2009)10238 of 10/12/2009
04/02/2010 Centralised - Variation EMEA/H/C/638/IB/27
09/08/2010 Centralised - Variation
31/08/2010 Centralised - Variation EMEA/H/C/638/II/31 (2010)6016 of 26/08/2010
27/09/2010 Centralised - Renewal EMEA/H/C/638/R/32 (2010)6715 of 23/09/2010
25/01/2011 Centralised - Variation EMEA/H/C/638/II/30/G, EMEA/H/C/638/II/29 (2011)403 of 21/01/2011
25/01/2011 Centralised - Variation EMEA/H/C/638/II/30/G (2011)404 of 21/01/2011
16/02/2011 Centralised - Variation EMEA/H/C/638/IB/36
28/03/2011 Centralised - Variation EMEA/H/C/638/IG/44/G
Updated with Decision(2011)3085 of 02/05/2011
30/03/2011 Centralised - Variation EMEA/H/C/638/II/35 (2011)2087 of 24/03/2011
04/05/2011 Centralised - Variation EMEA/H/C/638/II/28 (2011)3085 of 02/05/2011
26/10/2011 Centralised - Variation EMEA/H/C/638/II/41 (2011)7776 of 24/10/2011
27/10/2011 Centralised - Variation EMEA/H/C/638/N/38
Updated with Decision(2012)2027 of 21/03/2012
10/01/2012 Centralised - Variation EMEA/H/C/638/IB/42
Updated with Decision(2012)2027 of 21/03/2012
26/03/2012 Centralised - Variation EMEA/H/C/638/X/37 (2012)2027 of 21/03/2012
17/04/2012 Centralised - Variation EMEA/H/C/638/II/40 (2012)2549 of 13/04/2012
30/05/2012 Centralised - Variation EMEA/H/C/638/N/45
Updated with Decision(2012)4520 of 27/06/2012
02/07/2012 Centralised - Variation EMEA/H/C/638/II/44 (2012)4520 of 27/06/2012
13/12/2012 Centralised - Variation EMEA/H/C/638/II/48
Updated with Decision(2013)9480 of 13/12/2013
25/07/2013 Centralised - Variation EMEA/H/C/638/II/53
Updated with Decision(2013)9480 of 13/12/2013
30/07/2013 Centralised - Variation EMEA/H/C/638/N/54
Updated with Decision(2013)9480 of 13/12/2013
19/09/2013 Centralised - Variation EMEA/H/C/638/II/55
Updated with Decision(2013)9480 of 13/12/2013
21/11/2013 Centralised - Variation EMEA/H/C/638/II/57
17/12/2013 Centralised - Variation (2013)9480 of 13/12/2013
18/12/2013 Centralised - Variation EMEA/H/C/638/II/56
22/05/2014 Centralised - Variation EMEA/H/C/638/II/60