Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sildenafil Actavis   
Auth. number : EU/1/09/595
INN : 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.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

  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 EMEA/H/C/1090/IA/1
15/09/2011 Corrigendum
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 06/10/2011
16/01/2013 Centralised - Variation 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
01/10/2013 Centralised - Variation EMEA/H/C/1090/N/8
Updated with Decision(2014)1504 of 03/03/2014
04/11/2013 Centralised - Variation EMEA/H/C/1090/IB/9/G
Updated with Decision(2014)1504 of 03/03/2014
05/03/2014 Centralised - Variation (2014)1504 of 03/03/2014
25/04/2014 Centralised - Variation EMEA/H/C/1090/IA/11