Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Evra   
Auth. number : EU/1/02/223
INN : Norelgestromin / Ethinyl estradiol
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G03 - Sex hormones and modulators of the genital system
Pharmacological subgroup: G03A - Hormonal contraceptives for systemic use
Chemical subgroup: G03AA - Progestogens and estrogens, fixed combinations
Chemical substance: G03AA - Progestogens and estrogens, fixed combinations
(See WHO ATC Index)
Indication: Female contraception
EVRA is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.
The decision to prescribe EVRA should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with EVRA compares with other CHCs
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België

  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
26/08/2002 Centralised - Authorisation EMEA/H/C/410 (2002)3190 of 22/08/2002
19/02/2003 Centralised - Variation EMEA/H/C/410/I/2 (2003)614 of 17/02/2003
06/03/2003 Centralised - Variation EMEA/H/C/410/II/1 (2003)753 of 04/03/2003
24/04/2003 Centralised - Variation EMEA/H/C/410/I/3 (2003)1413 of 22/04/2003
07/10/2003 Centralised - Variation EMEA/H/C/410/N/4 (2003)3609 of 03/10/2003
07/04/2004 Centralised - Variation EMEA/H/C/410/IB/5
29/06/2004 Centralised - Variation EMEA/H/C/410/II/6
16/03/2005 Centralised - Variation EMEA/H/C/410/N/8
Updated with Decision(2007)267 of 25/01/2007
07/01/2006 Centralised - Variation EMEA/H/C/410/IB/11
17/07/2006 Centralised - Variation EMEA/H/C/410/N/12
Updated with Decision(2007)267 of 25/01/2007
29/01/2007 Centralised - Variation EMEA/H/C/410/II/13, 14 (2007)267 of 25/01/2007
11/09/2007 Centralised - Renewal EMEA/H/C/410/R/15 (2007)4252 of 07/09/2007
24/06/2008 Centralised - Variation EMEA/H/C/410/II/16 (2008)3153 of 20/06/2008
10/09/2008 Centralised - Variation EMEA/H/C/410/II/17 (2008)5049 of 08/09/2008
24/12/2008 Centralised - Variation EMEA/H/C/410/II/18 (2008)8980 of 22/12/2008
24/06/2009 Centralised - Variation EMEA/H/C/410/IA/20
24/06/2009 Centralised - Variation EMEA/H/C/410/IA/19
24/12/2009 Centralised - Variation EMEA/H/C/410/II/22 (2009)10752 of 22/12/2009
05/01/2010 Centralised - Variation EMEA/H/C/410/II/21
07/04/2010 Centralised - Variation EMEA/H/C/410/IA/23/G
30/07/2010 Centralised - Variation EMEA/H/C/410/IB/24
24/02/2012 Centralised - Variation EMEA/H/C/410/II/26 (2012)1274 of 21/02/2012
19/06/2012 Centralised - Renewal EMEA/H/C/410/R/27 (2012)4205 of 15/06/2012
14/02/2013 Centralised - Variation EMEA/H/C/410/IB/30
Updated with Decision(2014)316 of 16/01/2014
21/02/2013 Centralised - Variation EMEA/H/C/410/II/28
Updated with Decision(2014)316 of 16/01/2014
21/01/2014 Referral EMEA/H/C/410/A-31 (2014)316 of 16/01/2014