Terpenic derivatives

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


The European Medicines Agency has completed a review of the safety and effectiveness of suppositories containing terpenic derivatives. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the use of these medicines should be contraindicated in children under 30 months old, children with a history of epilepsy or febrile convulsion and children with a recent history of anorectal lesion (precancerous growths in the anus or rectum).

Key facts

Approved name
Terpenic derivatives
International non-proprietary name (INN) or common name

camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needle, eucalyptus and turpentine

Terpenic derivatives
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
EC decision 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 takenfor the marketing authorisation(s) such as safety measures or extra studies

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