Isotretinoin

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

Isotretinoin (13-cis-retinoic acid) is a retinoid compound and a derivative of vitamin A. Isotretinoin is used for the systemic treatment of acne. Like all retinoids, isotretinoin is teratogen and is contraindicated during pregnancy to avoid congenital defects.

A marketing authorisation for Isotretinoin was granted to Schering Health Care Ltd in UK, on 16 August 2001. The dossier was submitted as a so called “generic application”, as essentially similar to Roaccutane first authorised in EU in 1983. Applications for mutual recognition of Isotretinoin were submitted to Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal and Spain. The Mutual Recognition Procedure started on 4 February 2002.

On 3 May 2002, France presented to the EMEA a referral under Article 29 of Directive 2001/83/EC. The referral by France mainly related to the pregnancy prevention measures proposed for this generic product as reflected in the summary of product characteristics of the mutual recognition procedure.

The referral procedure started on 30 May 2002.

During its April 2003 meeting, the CPMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that a marketing authorisation should be granted provided amendment to the summary of product characteristics. In particular, isotretinoin (oral) should only be prescribed to women of childbearing potential under strict pregnancy prevention measures supported by a Pregnancy Prevention Programme (see annex III, amended summary of product characteristics). A positive opinion was therefore adopted on 25 April 2003.

The scientific conclusions and the grounds for the amendment of the Summary of Product Characteristics are set out in Annex II, together with the amended Summary of Product Characteristics in the Annex III.

The final opinion was converted into a Decision by the European Commission on 17 October 2003.

Key facts

Approved name
Isotretinoin
International non-proprietary name (INN) or common name

Isotretinoin

Reference number
CPMP/2811/03
Type
Article 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Status
European Commission final decision
Opinion date
25/04/2003
EC decision date
17/10/2003

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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