Ergot-derived dopamine agonists

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


The European Medicines Agency (EMEA) has completed a review of the safety of the ergot-derived dopamine agonists, a group of medicines that are mainly used to treat Parkinson's disease. The review focused on the risk of fibrosis (the formation of fibrous tissue in some body structures) in patients taking these medicines for long periods, particularly cardiac fibrosis (abnormal thickening of the heart valves). This review was carried out under an 'Article 31' referral1.

The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the marketing authorisations for these medicines should be maintained. However, restrictions on the way these medicines are used should be introduced, to reduce the risk of fibrosis developing.

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

Key facts

Approved name
Ergot-derived dopamine agonists
International non-proprietary name (INN) or common name
  • bromocriptine
  • cabergoline
  • dihydroergocryptine
  • lisuride
  • pergolide
Reference number
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.

European Commission final decision
Opinion date

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 taken for the marketing authorisation(s) such as safety measures or extra studies

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