Ibuprofen Kabi 400 mg Infusionslösung and associated names

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
Opinion provided by Committee for Medicinal Products for Human Use

Overview

EMA recommends authorisation of Ibuprofen Kabi (ibuprofen, 400 mg solution for infusion) in the EU

On 23 July 2020, the European Medicines Agency completed a review of Ibuprofen Kabi following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Ibuprofen Kabi outweigh its risks, and the marketing authorisation can be granted in Germany and in other Member States of the EU where the company has applied for a marketing authorisation (Austria, Belgium, Czechia, Hungary, the Netherlands, Poland, Portugal, Romania, Slovenia, Slovakia, Spain and the United Kingdom).

Key facts

Approved name
Ibuprofen Kabi 400 mg Infusionslösung and associated names
International non-proprietary name (INN) or common name

ibuprofen

Associated names
  • Ibuprofen Fresenius Kabi 400 mg oplossing voor infusie
  • Ibuprofen Fresenius Kabi 400 mg solution pour perfusion
  • Ibuprofen Kabi
  • Ibuprofen Kabi 400 mg oldatos infúzió
  • Ibuprofen Kabi 400 mg soluţie perfuzabilă
  • Ibuprofen Kabi 400 mg
  • Ibuprofen Kabi 400 mg raztopina za infundiranje
  • Ibuprofeno Kabi 400 mg solución para perfusion
  • Ibuprofen Kabi 400 mg Solution for Infusion
Reference number
EMEA/H/A-29(4)/1498
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
Opinion provided by Committee for Medicinal Products for Human Use
Opinion date
23/07/2020

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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