Modafinil

Current status:
European Commission final decision

Overview

Indications restricted following review procedure under Article 31 of Directive 2001/83/EC as amended.

The European Medicines Agency has completed a review of the safety and effectiveness of modafinil. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of modafinil-containing medicines continue to outweigh their risks but that their use should be restricted to the treatment of narcolepsy. The CHMP also recommended further changes to the product information to ensure that the medicines are used appropriately, and asked the manufacturers to put in place risk minimisation measures.

After re-examination, the Committee confirmed these recommendations on 18 November 2010.

Key facts

Approved name
Modafinil
International non-proprietary name (INN) or common name
modafinil
Associated names
  • Modasomil
  • Modiodal
  • Provigil
  • Vigil
Reference number
EMEA/H/A-31/1186
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
European Commission final decision
Opinion date
18/11/2010
EC decision date
27/01/2011

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

How useful was this page?

Add your rating