Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sildenafil ratiopharm   
Auth. number : EU/1/09/603
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: ratiopharm GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

  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
28/12/2009 Centralised - Authorisation EMEA/H/C/1080 (2009)10763 of 23/12/2009
19/02/2010 Centralised - Variation EMEA/H/C/1080/IA/1
Updated with Decision(2010)5618 of 06/08/2010
26/03/2010 Centralised - Variation EMEA/H/C/1080/IB/2/G
Updated with Decision(2010)5618 of 06/08/2010
12/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1080/IA/5
21/05/2010 Centralised - Variation EMEA/H/C/1080/IA/7/G
Updated with Decision(2010)5618 of 06/08/2010
02/06/2010 Centralised - Notification EMEA/H/C/1080/N/6
Updated with Decision(2011)2701 of 12/04/2011
11/08/2010 Centralised - Variation (2010)5618 of 06/08/2010
14/09/2010 Centralised - Variation EMEA/H/C/1080/IB/9
Updated with Decision(2011)2701 of 12/04/2011
29/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1080/IB/8/G
14/04/2011 Centralised - Variation (2011)2701 of 12/04/2011
18/07/2011 Centralised - Variation EMEA/H/C/1080/II/10 (2011)5200 of 13/07/2011
22/06/2012 Centralised - Notification EMEA/H/C/1080/N/13
Updated with Decision(2013)9150 of 09/12/2013
07/12/2012 Centralised - Variation EMEA/H/C/1080/IAin/16/G
Updated with Decision(2013)9150 of 09/12/2013
08/01/2013 Centralised - Variation EMEA/H/C/1080/IB/15
Updated with Decision(2013)9150 of 09/12/2013
06/03/2013 Centralised - Variation EMEA/H/C/1080/IB/19
Updated with Decision(2013)9150 of 09/12/2013
12/04/2013 Centralised - Variation EMEA/H/C/1080/IB/23
Updated with Decision(2013)9150 of 09/12/2013
08/05/2013 Centralised - Variation EMEA/H/C/1080/IB/22/G
Updated with Decision(2013)9150 of 09/12/2013
13/06/2013 Centralised - Variation EMEA/H/C/227/IAin/27/G
Updated with Decision(2013)9150 of 09/12/2013
30/08/2013 Centralised - Variation EMEA/H/C/1080/IB/30
Updated with Decision(2013)9150 of 09/12/2013
17/10/2013 Centralised - Variation EMEA/H/C/1080/IB/31
Updated with Decision(2013)9150 of 09/12/2013
11/12/2013 Centralised - Yearly update (2013)9150 of 09/12/2013
16/05/2014 Centralised - Variation EMEA/H/C/1080/IB/33/G
Updated with Decision(2014)6477 of 09/09/2014
11/09/2014 Centralised - Renewal EMEA/H/C/1080/R/35 (2014)6477 of 09/09/2014