Flurbiprofen Geiser

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

Overview

EMA recommends authorisation of Flurbiprofen Geiser (flurbiprofen, 8.75 mg, oromucosal spray) in the EU

On 17 October 2019, the European Medicines Agency completed a review of Flurbiprofen Geiser following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Flurbiprofen Geiser outweigh its risks, and the marketing authorisation can be granted in Spain and in other Member States of the EU where the company has applied for a marketing authorisation: Czech Republic, the Netherlands, Portugal and Slovakia.

Key facts

Approved name
Flurbiprofen Geiser
International non-proprietary name (INN) or common name

flurbiprofen

Associated names
  • Flurbiprofen Sejmet
  • Mentocaína Spray
  • Flurbiprofeno Geiser
Reference number
EMEA/H/A-29(4)/1487
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
17/10/2019
EC decision date
16/12/2019

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:

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