Flolan

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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).

What is Flolan?

Flolan is a medicine that contains the active substance epoprostenol. It is used to prevent blood clotting during haemodialysis (a technique for removing waste products from the blood used in patients with kidney disease). Flolan is also used to treat a lung condition called ‘pulmonary arterial hypertension’ (high blood pressure in the lungs).

The active substance in Flolan, epoprostenol, is a naturally occurring prostaglandin that works by stopping the blood from clotting. It stops the activation of the blood-clotting mechanism by preventing platelets (components that help the blood to clot) from sticking together. Epoprostenol also widens the blood vessels which helps to lower the blood pressure in the lungs.

Flolan is marketed in the following EU Member States: Austria, Belgium, the Czech Republic, Denmark, Estonia, France, Ireland, Italy, Luxembourg, Malta, the Netherlands, Spain and the United Kingdom, as well as Norway. It is also available under the trade name Epoprostenol.

The company that markets these medicines is GlaxoSmithKline.

Why was Flolan reviewed?

Flolan is authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Flolan was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures – Human (CMDh).

On 15 June 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Flolan in the EU.

What are the conclusions of the CHMP?

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

After reviewing the available data supporting the use of the medicine, the CHMP agreed that Flolan should be used for the following:

  • treatment of pulmonary arterial hypertension (PAH) (idiopathic or heritable PAH and PAH associated with connective tissue diseases) in patients with World Health Organization functional class III-IV symptoms to improve exercise capacity;
  • haemodialysis in emergency situations when the use of heparin carries a high risk of causing or exacerbating bleeding, or when heparin is otherwise contraindicated.

4.2 Posology and method of administration

Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Flolan in the elderly and patients with reduced kidney and liver function.

4.3 Contra-indications

In harmonising the contraindications, the CHMP decided to remove three contraindications that were in the SmPCs of some EU countries: pulmonary veno-occlusive disease, hypotension and angina. The CHMP was of the view that patients with pulmonary veno-occlusive disease could benefit from treatment with Flolan and that for hypotension and angina it was more appropriate to include relevant warnings in section 4.4.

Other changes

The CHMP also harmonised other sections of the SmPC including sections 4.6 (pregnancy and lactation), 4.5 (interaction with other medicinal products and other forms of interaction) and 4.8 (side effects).

The amended information to doctors and patients is available under the 'All documents' tab.

A European Commission issued a decision on 8 August 2012.

Name Language First published Last updated
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) BG = bălgarski 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) ES = español 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) CS = čeština 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) DA = dansk 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) DE = Deutsch 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) ET = eesti keel 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) EL = elliniká 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) EN = English 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) FR = français 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) IT = italiano 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) LV = latviešu valoda 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) LT = lietuvių kalba 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) HU = magyar 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) MT = Malti 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) NL = Nederlands 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) PL = polski 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) PT = português 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) RO = română 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) SK = slovenčina 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) SL = slovenščina 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) FI = suomi 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) SV = svenska 25/05/2012 14/09/2012

Key facts

Approved nameFlolan
International non-proprietary name (INN) or common name

epoprostenol

Associated namesEpoprostenol
Class
Reference numberEMEA/H/A-30/1299
TypeArticle 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 European Union.

StatusEuropean Commission final decision
Opinion date24/05/2012

All documents

Name Language First published Last updated
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) BG = bălgarski 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) ES = español 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) CS = čeština 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) DA = dansk 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) DE = Deutsch 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) ET = eesti keel 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) EL = elliniká 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) EN = English 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) FR = français 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) IT = italiano 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) LV = latviešu valoda 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) LT = lietuvių kalba 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) HU = magyar 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) MT = Malti 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) NL = Nederlands 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) PL = polski 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) PT = português 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) RO = română 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) SK = slovenčina 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) SL = slovenščina 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) FI = suomi 25/05/2012 14/09/2012
Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion) SV = svenska 25/05/2012 14/09/2012
Flolan - Article 30 - Annex I BG = bălgarski 14/09/2012  
Flolan - Article 30 - Annex I ES = español 14/09/2012  
Flolan - Article 30 - Annex I CS = čeština 14/09/2012  
Flolan - Article 30 - Annex I DA = dansk 14/09/2012  
Flolan - Article 30 - Annex I DE = Deutsch 14/09/2012  
Flolan - Article 30 - Annex I ET = eesti keel 14/09/2012  
Flolan - Article 30 - Annex I EL = elliniká 14/09/2012  
Flolan - Article 30 - Annex I EN = English 14/09/2012  
Flolan - Article 30 - Annex I FR = français 14/09/2012  
Flolan - Article 30 - Annex I IT = italiano 14/09/2012  
Flolan - Article 30 - Annex I LV = latviešu valoda 14/09/2012  
Flolan - Article 30 - Annex I LT = lietuvių kalba 14/09/2012  
Flolan - Article 30 - Annex I HU = magyar 14/09/2012  
Flolan - Article 30 - Annex I MT = Malti 14/09/2012  
Flolan - Article 30 - Annex I NL = Nederlands 14/09/2012  
Flolan - Article 30 - Annex I PL = polski 14/09/2012  
Flolan - Article 30 - Annex I PT = português 14/09/2012  
Flolan - Article 30 - Annex I RO = română 14/09/2012  
Flolan - Article 30 - Annex I SK = slovenčina 14/09/2012  
Flolan - Article 30 - Annex I SL = slovenščina 14/09/2012  
Flolan - Article 30 - Annex I FI = suomi 14/09/2012  
Flolan - Article 30 - Annex I SV = svenska 14/09/2012  
Flolan - Article 30 - Annex II BG = bălgarski 14/09/2012  
Flolan - Article 30 - Annex II ES = español 14/09/2012  
Flolan - Article 30 - Annex II CS = čeština 14/09/2012  
Flolan - Article 30 - Annex II DA = dansk 14/09/2012  
Flolan - Article 30 - Annex II DE = Deutsch 14/09/2012  
Flolan - Article 30 - Annex II ET = eesti keel 14/09/2012  
Flolan - Article 30 - Annex II EL = elliniká 14/09/2012  
Flolan - Article 30 - Annex II EN = English 14/09/2012  
Flolan - Article 30 - Annex II FR = français 14/09/2012  
Flolan - Article 30 - Annex II IT = italiano 14/09/2012  
Flolan - Article 30 - Annex II LV = latviešu valoda 14/09/2012  
Flolan - Article 30 - Annex II LT = lietuvių kalba 14/09/2012  
Flolan - Article 30 - Annex II HU = magyar 14/09/2012  
Flolan - Article 30 - Annex II MT = Malti 14/09/2012  
Flolan - Article 30 - Annex II NL = Nederlands 14/09/2012  
Flolan - Article 30 - Annex II PL = polski 14/09/2012  
Flolan - Article 30 - Annex II PT = português 14/09/2012  
Flolan - Article 30 - Annex II RO = română 14/09/2012  
Flolan - Article 30 - Annex II SK = slovenčina 14/09/2012  
Flolan - Article 30 - Annex II SL = slovenščina 14/09/2012  
Flolan - Article 30 - Annex II FI = suomi 14/09/2012  
Flolan - Article 30 - Annex II SV = svenska 14/09/2012  
Flolan - Article 30 - Annex III BG = bălgarski 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III ES = español 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III CS = čeština 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III DA = dansk 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III DE = Deutsch 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III ET = eesti keel 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III EL = elliniká 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III EN = English 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III FR = français 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III IT = italiano 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III LV = latviešu valoda 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III LT = lietuvių kalba 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III HU = magyar 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III MT = Malti 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III NL = Nederlands 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III PL = polski 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III PT = português 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III RO = română 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III SK = slovenčina 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III SL = slovenščina 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III FI = suomi 06/07/2012 14/09/2012
Flolan - Article 30 - Annex III SV = svenska 06/07/2012 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 have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

More information on Flolan