Flurbiprofen Geiser
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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 |
|
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
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Flurbiprofen Geiser Article 29(4) referral - EMA recommends authorisation of Flurbiprofen Geiser (flurbiprofen, 8.75 mg, oromucosal spray) in the EU (PDF/147.43 KB)
Adopted
First published: 18/10/2019
Last updated: 20/01/2020
EMA/631051/2019 -
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Flurbiprofen Geiser Article 29(4) referral - Annex I (PDF/56.52 KB)
First published: 20/01/2020 -
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Flurbiprofen Geiser Article 29(4) referral - Annex II (PDF/77.17 KB)
First published: 20/01/2020 -
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Flurbiprofen Geiser Article 29(4) referral - Annex III (PDF/63.05 KB)
First published: 18/10/2019 -
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Flurbiprofen Geiser Article 29(4) referral - Assessment report (PDF/232.21 KB)
Adopted
First published: 19/12/2019
EMA/589361/2019
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