Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vaniqa   
Auth. number : EU/1/01/173
INN : eflornithine
ATC: Anatomical main group: D - Dermatologicals
Therapeutic subgroup: D11 - Other dermatological preparations
Pharmacological subgroup: D11A - Other dermatological preparations
Chemical subgroup: D11AX - Other dermatologicals
Chemical substance: D11AX16 - Eflornithine
(See WHO ATC Index)
Indication: Treatment of facial hirsutism in women
Marketing Authorisation Holder: Almirall, S.A.
Ronda General Mitre, 151, E-08022 Barcelona, España

  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
22/03/2001 Centralised - Authorisation EMEA/H/C/325 (2001)769 of 20/03/2001
13/06/2001 Centralised - Variation EMEA/H/C/325/I/1
19/07/2001 Centralised - Variation EMEA/H/C/325/I/2
13/02/2002 Centralised - Variation EMEA/H/C/325/I/4
05/03/2002 Centralised - Variation EMEA/H/C/325/I/3 (2002)937 of 28/02/2002
12/08/2003 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/325/T/5 (2003)2941 of 05/08/2003
08/03/2004 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/325/T/6 (2004)774 of 04/03/2004
19/03/2004 Centralised - Variation EMEA/H/C/325/IA/7
Updated with Decision(2004)4053 of 13/10/2004
26/03/2004 Centralised - Variation EMEA/H/C/325/IA/8
18/10/2004 Centralised - Variation EMEA/H/C/325 (2004)4053 of 13/10/2004
22/10/2004 Centralised - Variation EMEA/H/C/325/IB/9
Updated with Decision(2005)2947 of 27/07/2005
12/01/2005 Centralised - Variation EMEA/H/C/325/N/10
Updated with Decision(2005)2947 of 27/07/2005
04/03/2005 Centralised - Variation EMEA/H/C/325/IA/13
Updated with Decision(2005)2947 of 27/07/2005
04/03/2005 Centralised - Variation EMEA/H/C/325/IA/12
08/03/2005 Centralised - Variation EMEA/H/C/325/N/11
Updated with Decision(2005)2947 of 27/07/2005
27/05/2005 Centralised - Variation EMEA/H/C/325/IA/15
02/06/2005 Centralised - Variation EMEA/H/C/325/IB/14
20/07/2005 Centralised - Variation EMEA/H/C/325/IB/16
29/07/2005 Centralised - Variation EMEA/H/C/325 (2005)2947 of 27/07/2005
12/08/2005 Centralised - Variation EMEA/H/C/325/N/17
Updated with Decision(2006)1690 of 18/04/2006
29/09/2005 Centralised - Variation EMEA/H/C/325/IA/18
12/12/2005 Centralised - Variation EMEA/H/C/325/IA/19
20/04/2006 Centralised - Renewal EMEA/H/C/325/R/20 (2006)1690 of 18/04/2006
28/09/2006 Centralised - Variation EMEA/H/C/325/IB/22
28/09/2006 Centralised - Variation EMEA/H/C/325/IB/22
15/12/2006 Centralised - Variation EMEA/H/C/325/IB/24
15/12/2006 Centralised - Variation EMEA/H/C/325/IB/23
25/05/2007 Centralised - Variation EMEA/H/C/325/N/25
Updated with Decision(2007)3206 of 27/06/2007
29/06/2007 Centralised - Variation EMEA/H/C/325/II/26 (2007)3206 of 27/06/2007
13/11/2007 Centralised - Variation EMEA/H/C/325/IA/27
11/06/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/325/T/28 (2008)2688 of 06/06/2008
14/08/2009 Centralised - Variation EMEA/H/C/325/IA/29
Updated with Decision(2010)1757 of 15/03/2010
14/08/2009 Centralised - Variation EMEA/H/C/325/IA/30
Updated with Decision(2010)1757 of 15/03/2010
26/11/2009 Centralised - Variation EMEA/H/C/325/IB/32
Updated with Decision(2010)1757 of 15/03/2010
26/11/2009 Centralised - Variation EMEA/H/C/325/IB/31
17/03/2010 Centralised - Variation (2010)1757 of 15/03/2010
04/10/2010 Centralised - Variation EMEA/H/C/325/IA/33
Updated with Decision(2011)1607 of 04/03/2011
08/03/2011 Centralised - Renewal EMEA/H/C/325/R/34 (2011)1607 of 04/03/2011
10/04/2013 Centralised - Variation EMEA/H/C/325/IB/38
Updated with Decision(2014)3558 of 22/05/2014
09/04/2014 Centralised - Variation EMEA/H/C/325//N/44
Updated with Decision(2014)3558 of 22/05/2014
03/06/2014 Centralised - Variation (2014)3558 of 22/05/2014