Methylphenidate

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

Overview

The European Medicines Agency (EMEA) has completed a review of the safety of medicines containing methylphenidate. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of these medicines continue to outweigh their risks when used to treat children aged six years and above and adolescents with attention deficit/hyperactivity disorder (ADHD). However, the Committee has concluded that the prescribing information for these medicines should be made consistent, in order to maximise their safe use across the European Union (EU). The review was carried out under an 'Article 31' referral1.

1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.

Key facts

Approved name
Methylphenidate
International non-proprietary name (INN) or common name
methylphenidate
Reference number
EMEA/658285/2008
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
22/01/2009
EC decision date
27/05/2009

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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