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Community register of medicinal products for human use


Product information

Invented name: Sildenafil Actavis   
Auth. number : EU/1/09/595
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: Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil Actavis to be effective, sexual stimulation is required.
Marketing Authorisation Holder: Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland
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
14/12/2009 Centralised - Authorisation EMEA/H/C/1090 (2009)10228 of 10/12/2009
25/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1090/IA/1
15/09/2011 Corrigendum (2011)7247 of 6/10/2011
10/10/2011 Centralised - Variation EMEA/H/C/1090/IB/2
Updated with Decision(2011)7247 of 06/10/2011
10/10/2011 Centralised - Variation (2011)7247 of 6/10/2011
16/01/2013 Centralised - Notification EMEA/H/C/1090/N/4
Updated with Decision(2014)1504 of 03/03/2014
20/03/2013 Centralised - Variation EMEA/H/C/1090/IB/6
Updated with Decision(2014)1504 of 03/03/2014
1/10/2013 Centralised - Notification EMEA/H/C/1090/N/8
Updated with Decision(2014)1504 of 03/03/2014
4/11/2013 Centralised - Variation EMEA/H/C/1090/IB/9/G
Updated with Decision(2014)1504 of 03/03/2014
5/03/2014 Centralised - Yearly update (2014)1504 of 3/03/2014
25/04/2014 Centralised - Variation EMEA/H/C/1090/IA/11
Updated with Decision(2014)6358 of 04/09/2014
8/09/2014 Centralised - Renewal EMEA/H/C/1090/R/10 (2014)6358 of 4/09/2014
27/01/2016 Centralised - 2-Monthly update EMEA/H/C/1090/IB/14 (2016)461 of 25/01/2016
6/06/2016 Centralised - Variation EMEA/H/C/1090/IB/17/G
Updated with Decision(2017)3655 of 22/05/2017
24/05/2017 Centralised - Yearly update (2017)3655 of 22/05/2017
6/04/2018 Centralised - Notification EMEA/H/C/1090/N/18