Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zoely   
Auth. number : EU/1/11/690
INN : nomegestrol / 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: G03AA14 - Nomegestrol and ethinylestradiol
(See WHO ATC Index)
Indication: Oral contraception.
Marketing Authorisation Holder: Teva B.V.
Swensweg 5, 2031 GA Haarlem, 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
01/08/2011 Centralised - Authorisation EMEA/H/C/1213 (2011)5599 of 27/07/2011
15/11/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1213/T/1 (2011)8244 of 10/11/2011
21/12/2011 Centralised - Variation EMEA/H/C/1213/N/3
Updated with Decision(2012)7881 of 29/10/2012
24/04/2012 Centralised - Rectificative EMEA/H/C/1213 (2012)2827 of 20/04/2012
21/06/2012 Centralised - Variation EMEA/H/C/1213/IB/7/G
Updated with Decision(2012)7881 of 29/10/2012
02/08/2012 Centralised - Variation EMEA/H/C/1213/IB/6/G
Updated with Decision(2012)7881 of 29/10/2012
09/11/2012 Centralised - Variation (2012)7881 of 29/10/2012
03/12/2012 Centralised - Variation EMEA/H/C/1213/N/9
Updated with Decision(2013)3772 of 11/06/2013
24/04/2013 Centralised - Variation EMEA/H/C/1213/IB/12/G
Updated with Decision(2014)322 of 16/01/2014
18/06/2013 Centralised - Modification EMEA/H/C/1213/PSU/5 (2013)3772 of 11/06/2013
23/08/2013 Centralised - Variation EMEA/H/C/1213/N/13
Updated with Decision(2014)322 of 16/01/2014
16/10/2013 Centralised - Variation EMEA/H/C/1213/IB/14
Updated with Decision(2014)322 of 16/01/2014
23/01/2014 Referral EMEA/H/C/1213/A-31/10 (2014)322 of 16/01/2014
08/05/2014 Centralised - Variation EMEA/H/C/1213/IAIN/19/G
Updated with Decision(2014)6270 of 01/09/2014
26/06/2014 Centralised - Variation EMEA/H/C/1213/N/22
Updated with Decision(2014)6270 of 01/09/2014
04/09/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1213/T/23 (2014)6270 of 01/09/2014