Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets

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

Overview

On 18 May 2017, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Paracetamol/ibuprofen 500mg/150mg film-coated tablets. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Paracetamol/ibuprofen 500mg/150mg film-coated tablets outweigh its risks, and the marketing authorisation can be granted
in the United Kingdom and in the following Member States of the EU: Austria, Belgium, Croatia, France, Germany, Ireland, Luxembourg, the Netherlands, Portugal and Spain.

Key facts

Approved name
Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets
International non-proprietary name (INN) or common name
paracetamol-ibuprofen
Associated names
Paracomb
Reference number
EMEA/H/A-29(4)/1447
Type
Article 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Status
European Commission final decision
Opinion date
18/05/2017
EC decision date
07/08/2017

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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