Roaccutane

  • 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.

Roaccutane was registered in all EU Member States, except Sweden, from 1983.

On 29 May 2002, France presented to the EMEA a referral under Article 30 of Directive 2001/83/EC. The rationale for the article 30 referral of Roaccutane was due to the fact that Roaccutane does not have the same summary of product characteristics across Member States due to divergent national decisions.

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 the summary of product characteristics should be amended. 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
Roaccutane
International non-proprietary name (INN) or common name
Isotretinoin
Reference number
CPMP/2846/03
Type
Article 30 referrals

This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

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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