Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: IOA   
Auth. number : EU/1/11/689
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: Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

  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
18/11/2011 Centralised - Authorisation EMEA/H/C/2068 (2011)8514 of 16/11/2011
29/02/2012 Centralised - Variation EMEA/H/C/2068/N/4
Updated with Decision(2013)3773 of 11/06/2013
24/04/2012 Centralised - Rectificative EMEA/H/C/2068 (2012)2826 of 20/04/2012
03/12/2012 Centralised - Variation EMEA/H/C/2068/N/6
Updated with Decision(2013)3773 of 11/06/2013
13/06/2013 Centralised - Modification EMEA/H/C/2068/PSU/5 (2013)3773 of 11/06/2013
19/08/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2068/T/8 (2013)5484 of 14/08/2013
16/10/2013 Centralised - Variation EMEA/H/C/2068/IB/9
Updated with Decision(2014)321 of 16/01/2014
21/01/2014 Referral EMEA/H/C/2068/7 (2014)321 of 16/01/2014