Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zoely   
Auth. number : EU/1/11/690
Active substance : 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: Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
1/08/2011 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 - Notification 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
2/08/2012 Centralised - Variation EMEA/H/C/1213/IB/6/G
Updated with Decision(2012)7881 of 29/10/2012
9/11/2012 Centralised - Variation (2012)7881 of 29/10/2012
3/12/2012 Centralised - Notification 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 PSUSA - Modification EMEA/H/C/1213/PSU/5 (2013)3772 of 11/06/2013
25/07/2013 Referral EMEA/H/C/1213/A-10a
23/08/2013 Centralised - Notification 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
8/05/2014 Centralised - Variation EMEA/H/C/1213/IAIN/19/G
Updated with Decision(2014)6270 of 01/09/2014
26/06/2014 Centralised - Notification EMEA/H/C/1213/N/22
Updated with Decision(2014)6270 of 01/09/2014
4/09/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1213/T/23 (2014)6270 of 1/09/2014
23/04/2015 Centralised - Variation EMEA/H/C/1213/II/27
Updated with Decision(2016)2543 of 21/04/2016
22/06/2015 Centralised - Notification EMEA/H/C/1213/N/29
Updated with Decision(2016)2543 of 21/04/2016
10/12/2015 Centralised - Variation EMEA/H/C/1213/IA/33
Updated with Decision(2016)2543 of 21/04/2016
7/04/2016 Centralised - Notification EMEA/H/C/1213/N/34
Updated with Decision(2017) 6779 of 03/10/2017
25/04/2016 Centralised - Renewal EMEA/H/C/1213/R/32 (2016)2543 of 21/04/2016
15/09/2016 Centralised - Variation EMEA/H/C/1213/II/35
Updated with Decision(2017) 6779 of 03/10/2017
16/12/2016 Centralised - Variation EMEA/H/C/1213/IAIN/39
Updated with Decision(2017) 6779 of 03/10/2017
9/02/2017 Centralised - Variation EMEA/H/C/1213/II/37
Updated with Decision(2017) 6779 of 03/10/2017
9/02/2017 Centralised - Variation EMEA/H/C/1213/II/38
Updated with Decision(2017) 6779 of 03/10/2017
5/10/2017 Centralised - Yearly update (2017) 6779 of 3/10/2017
8/12/2017 Centralised - Variation EMEA/H/C/1213/IAIN/40/G
Updated with Decision(2019)684 of 23/01/2019
15/12/2017 Centralised - Variation EMEA/H/C/1213/N/41
Updated with Decision(2019)684 of 23/01/2019
12/07/2018 Centralised - Variation EMEA/H/C/1213/IA/45/G
Updated with Decision(2019)684 of 23/01/2019
24/10/2018 Centralised - Notification EMEA/H/C/1213/N/46
Updated with Decision(2019)684 of 23/01/2019
18/01/2019 Centralised - Variation EMEA/H/C/1213/IAIN/48
25/01/2019 Centralised - Yearly update (2019)684 of 23/01/2019
4/02/2019 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1213/T/47 (2019)850 of 31/01/2019