Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sildenafil Teva   
Auth. number : EU/1/09/584
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
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland

  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
02/12/2009 Centralised - Authorisation EMEA/H/C/1073 (2009)9817 of 30/11/2009
12/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1073/IA/1
18/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1073/IB/4
26/04/2010 Centralised - Variation EMEA/H/C/1073/II/3 (2010)2638 of 22/04/2010
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1073/II/2
29/09/2010 Centralised - Variation EMEA/H/C/1073/IA/5
Updated with Decision(2010)8658 of 29/11/2010
21/10/2010 Centralised - Variation EMEA/H/C/1073/IB/6
Updated with Decision(2010)8658 of 29/11/2010
28/10/2010 Centralised - Variation EMEA/H/C/1073/IA/7/G
Updated with Decision(2010)8658 of 29/11/2010
02/12/2010 Centralised - Variation (2010)8658 of 29/11/2010
01/06/2012 Centralised - Variation EMEA/H/C/1073/IA/10/G
Updated with Decision(2012)6398 of 10/09/2012
12/09/2012 Centralised - Variation (2012)6398 of 10/09/2012
08/02/2013 Centralised - Variation EMEA/H/C/1073/IB/16/G
Updated with Decision(2014)639 of 31/01/2014
13/03/2013 Centralised - Variation EMEA/H/C/1073/IB/18
Updated with Decision(2014)639 of 31/01/2014
23/10/2013 Centralised - Variation EMEA/H/C/1073/IB/23/G
Updated with Decision(2014)639 of 31/01/2014
05/02/2014 Centralised - Yearly update (2014)639 of 31/01/2014
12/09/2014 Centralised - Renewal EMEA/H/C/1073/R/25 (2014)6478 of 09/09/2014
27/11/2014 Centralised - Variation EMEA/H/C/1073/IA/27