Syner-Kinase and associated names
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Current status:
European Commission final decision
Overview
EMA completes review following disagreement among EU Member States
On 28 February 2019, the European Medicines Agency completed a review of Syner-Kinase and associated names following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Syner-Kinase outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.
Key facts
Approved name |
Syner-Kinase and associated names
|
International non-proprietary name (INN) or common name |
urokinase |
Reference number |
EMA-H-A-29(4)-1472
|
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 |
28/02/2019
|
EC decision date |
16/05/2019
|
All documents
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List item
Syner-Kinase Article 29(4) referral - EMA recommends authorisation of Syner-Kinase (urokinase) in the EU (PDF/76.6 KB)
Adopted
First published: 01/03/2019
Last updated: 03/06/2019
EMA/299749/2019 -
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List item
Syner-Kinase Article 29(4) referral - Annex III (PDF/22.11 KB)
First published: 01/03/2019
Last updated: 03/06/2019 -
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List item
Syner-Kinase Article 29(4) referral - Annex I (PDF/86.63 KB)
Adopted
First published: 03/06/2019 -
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List item
Syner-Kinase Article 29(4) referral - Annex II (PDF/36.11 KB)
Adopted
First published: 03/06/2019 -
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List item
Syner-Kinase Article 29(4) referral - CHMP assessment report (PDF/840.7 KB)
Adopted
First published: 03/06/2019
EMA/294785/2019
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