Overview
The marketing authorisation for Ioa has been withdrawn at the request of the marketing-authorisation holder.
Ioa : EPAR - Summary for the public
Product information
Ioa : EPAR - Product information
Latest procedure affecting product information: A31/0007
16/01/2014
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Ioa : EPAR - All authorised presentations
Product details
- Name of medicine
- Ioa
- Active substance
- Nomegestrol acetate
- estradiol
- International non-proprietary name (INN) or common name
- nomegestrol acetate
- estradiol
- Therapeutic area (MeSH)
- Contraception
- Anatomical therapeutic chemical (ATC) code
- G03AA14
Pharmacotherapeutic group
Sex hormones and modulators of the genital systemTherapeutic indication
Oral contraception.
Assessment history
Ioa : EPAR - Procedural steps taken and scientific information after authorisation
Ioa-H-C-2068-A31-1356 : EPAR - Assessment Report - Article 31
Ioa : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation. CHMP members’ divergent positions
Ioa-H-C-2068-PSU-05 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation