Flolan
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Current status:
European Commission final decision
Overview
On 24 May 2012, the European Medicines Agency completed a review of Flolan. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Flolan in the European Union (EU).
Key facts
Approved name |
Flolan
|
International non-proprietary name (INN) or common name |
epoprostenol |
Associated names |
Epoprostenol
|
Reference number |
EMEA/H/A-30/1299
|
Type |
Article 30 referrals
This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU. |
Status |
European Commission final decision
|
Opinion date |
24/05/2012
|
EC decision date |
08/08/2012
|
All documents
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Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) (PDF/91.88 KB)
Adopted
First published: 25/05/2012
Last updated: 14/09/2012
EMA/CHMP/329168/2012 Rev.1 -
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Flolan - Article 30 - Annex I (PDF/173.13 KB)
First published: 14/09/2012
Last updated: 14/09/2012 -
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Flolan - Article 30 - Annex II (PDF/73.85 KB)
First published: 14/09/2012
Last updated: 14/09/2012 -
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Flolan - Article 30 - Annex III (PDF/660.29 KB)
First published: 06/07/2012
Last updated: 14/09/2012 -
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