Elidel

Current status:
European Commission final decision

Overview

Following a request from the European Commission and Denmark, the Committee for Medicinal Products for Human Use (CHMP) has reviewed the safety data on medicines containing tacrolimus and pimecrolimus, used topically (on the skin) for the treatment of atopic dermatitis. They concluded that the benefits of these products still outweigh the risks, but recommended some changes to the prescribing information.

Key facts

Approved name
Elidel
International non-proprietary name (INN) or common name
pimecrolimus
Reference number
CHMP/80270/06, CHMP/262776/05
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
23/03/2006

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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