Ioa

Withdrawn

This medicine's authorisation has been withdrawn

nomegestrol acetate / estradiol

Overview

The marketing authorisation for Ioa has been withdrawn at the request of the marketing-authorisation holder.

Ioa : EPAR - Summary for the public

Reference Number: EMA/CHMP/906885/2011

Product information

Ioa : EPAR - Product information

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 system

Therapeutic indication

Oral contraception.

Authorisation details

• EMA product number:
  EMEA/H/C/002068
• Marketing authorisation holder:
  N.V. Organon

  Kloosterstraat 6; 5349 AB Oss; The Netherlands

• Marketing authorisation issued:
  16/11/2011
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

Ioa : EPAR - Procedural steps taken and scientific information after authorisation

Ioa-H-C-2068-A31-1356 : EPAR - Assessment Report - Article 31

AdoptedReference Number: EMA/739865/2013

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

Reference Number: EMA/721264/2013

Initial marketing authorisation documents

Ioa : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Ioa

AdoptedReference Number: EMA/CHMP/195954/2011