Durogesic and associated names

Current status:
Opinion provided by Committee for Medicinal Products for Human Use

Overview

On 21 July 2016, the European Medicines Agency completed a review of Durogesic. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Durogesic in the European Union (EU).

Key facts

Approved name
Durogesic and associated names
International non-proprietary name (INN) or common name
fentanyl
Reference number
EMEA/H/A-30/1413
Type
Article 30 referrals

This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Status
Opinion provided by Committee for Medicinal Products for Human Use
Opinion date
21/07/2016
EC decision date
22/09/2016

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:

News

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