Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vizarsin   
Auth. number : EU/1/09/551
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 Vizarsin to be effective, sexual stimulation is required.
Marketing Authorisation Holder: Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija

  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
23/09/2009 Centralised - Authorisation EMEA/H/C/1076 (2009)7410 of 21/09/2009
12/11/2009 Centralised - Variation EMEA/H/C/1076/IA/1
23/11/2009 Centralised - Variation EMEA/H/C/1076/IA/2
23/08/2010 Centralised - Variation EMEA/H/C/1076/IB/3
Updated with Decision(2011)2256 of 28/03/2011
16/12/2010 Centralised - Variation EMEA/H/C/1076/IA/4
28/01/2011 Centralised - Variation EMEA/H/C/1076/IA/5
30/03/2011 Centralised - Variation (2011)2256 of 28/03/2011
25/08/2011 Centralised - Variation EMEA/H/C/1076/IB/7
Updated with Decision(2012)1856 of 15/03/2012
28/11/2011 Centralised - Variation EMEA/H/C/1076/N/10
Updated with Decision(2012)1856 of 15/03/2012
19/03/2012 Centralised - Variation (2012)1856 of 15/03/2012
17/05/2012 Centralised - Variation EMEA/H/C/1076/X/6 (2012)3316 of 15/05/2012
18/12/2012 Centralised - Variation EMEA/H/C/1076/IB/12
Updated with Decision(2013)9839 of 20/12/2013
14/03/2013 Centralised - Variation EMEA/H/C/1076/IB/13
Updated with Decision(2013)9839 of 20/12/2013
17/07/2013 Centralised - Variation EMEA/H/C/1076/N/15
Updated with Decision(2013)9839 of 20/12/2013
10/10/2013 Centralised - Variation EMEA/H/C/1076/IB/16/G
Updated with Decision(2013)9839 of 20/12/2013
26/11/2013 Centralised - Variation EMEA/H/C/1076/IB/17
Updated with Decision(2013)9839 of 20/12/2013
24/12/2013 Centralised - Variation (2013)9839 of 20/12/2013
20/05/2014 Centralised - Renewal EMEA/H/C/1076/R/18 (2014)3413 of 16/05/2014