Ioa

Withdrawn

This medicine's authorisation has been withdrawn

nomegestrol acetate / estradiol

Overview

On 16 November 2011, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Ioa, which had been approved for oral contraception. The marketing authorisation holder (MAH) responsible for Ioa was Merck Sharp & Dohme Limited. 

On 31 July 2014, the European Commission issued a decision to withdraw the marketing authorisation for Ioa, following its receipt of a letter dated 18 June 2014 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reasons. Ioa was not marketed in any European country. 

Pursuant to this decision, the European public assessment report for Ioa is updated to reflect that the marketing authorisation is no longer valid.

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:
  Organon N.V.

  Kloosterstraat 6; 5349 AB Oss; The Netherlands

• Marketing authorisation issued:
  16/11/2011
• Withdrawal of marketing authorisation:
  31/07/2014
• 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

Adopted Reference 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

Adopted Reference Number: EMA/CHMP/195954/2011