Flutiform

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On 19 April 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Flutiform and Iffeza and associated names. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Flutiform and Iffeza outweigh the risks, and that the marketing authorisation can be granted in the United Kingdom (UK) and in the following Member States of the EU: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden.

What are Flutiform and Iffeza?

Flutiform and Iffeza are asthma medicines containing two active substances, fluticasone propionate and formoterol fumarate. They are to be used for the treatment of asthma in situations where the combination of an inhaled corticosteroid (such as fluticasone propionate) and a long-acting beta-2 agonist (such as formoterol fumarate) is appropriate.

Fluticasone propionate is an inhaled corticosteroid with high local anti-inflammatory activity and has been shown to reduce symptoms of asthma and reduce exacerbations of asthma.

The selective long-acting beta-2 agonist formoterol fumarate exerts an effect on beta-2 receptors on the smooth muscle in the lung to produce relaxation of the airways and bronchodilatation.  When inhaled, formoterol fumarate helps to keep the airways open allowing the patient to breathe more easily.

Flutiform will also be marketed as Flofera and Flutiformo.

Why were Flutiform and Iffeza reviewed?

Napp Pharmaceuticals Ltd submitted marketing authorisation applications for Flutiform and Iffeza and associated names to the UK medicines regulatory agency under the decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance the UK) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States’, in this instance Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden).

However, the Member States were not able to reach an agreement and the UK referred the matter to the CHMP for arbitration on 22 December 2011.

The grounds for the referral were concerns raised by the Netherlands over data showing that the levels of fluticasone propionate in the blood following dosing with Flutiform and Iffeza are lower than when fluticasone propionate is given alone, which may indicate a lower amount of fluticasione propionate being deposited in the lungs. In the light of this, the Netherlands questioned the long-term efficacy of this product in respect of asthma control.

What are the conclusions of the CHMP?

The CHMP looked at all the available evidence on the benefits and risks of the medicine in the treatment of asthma and concluded that the questions raised over its long-term effectiveness had been adequately addressed. Therefore, the Committee concluded that the benefits of Flutiform and Iffeza outweigh the risks and that marketing authorisation should be granted in all concerned Member States.

The European Commission issued a decision on 28 June 2012.

Name Language First published Last updated
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) BG = bălgarski 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) ES = español 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) CS = čeština 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) DA = dansk 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) DE = Deutsch 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) ET = eesti keel 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) EL = elliniká 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) EN = English 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) FR = français 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) IT = italiano 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) LV = latviešu valoda 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) LT = lietuvių kalba 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) HU = magyar 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) MT = Malti 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) NL = Nederlands 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) PL = polski 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) PT = português 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) RO = română 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) SK = slovenčina 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) SL = slovenščina 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) FI = suomi 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) SV = svenska 20/04/2012 25/10/2012

Key facts

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

fluticasone propionate / formoterol fumarate

Associated namesIffeza, Flofera, Flutiformo
Class
Reference numberEMEA/H/A-29/001326
TypeArticle 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a medicine being evaluated during a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

StatusEuropean Commission final decision
Opinion date19/04/2012

All documents

Name Language First published Last updated
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) BG = bălgarski 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) ES = español 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) CS = čeština 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) DA = dansk 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) DE = Deutsch 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) ET = eesti keel 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) EL = elliniká 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) EN = English 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) FR = français 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) IT = italiano 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) LV = latviešu valoda 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) LT = lietuvių kalba 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) HU = magyar 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) MT = Malti 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) NL = Nederlands 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) PL = polski 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) PT = português 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) RO = română 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) SK = slovenčina 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) SL = slovenščina 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) FI = suomi 20/04/2012 25/10/2012
Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) SV = svenska 20/04/2012 25/10/2012
Flutiform - Article 29 referral - Assessment report (English only) 25/10/2012  
Flutiform - Article 29 referral - Annex I BG = bălgarski 25/10/2012  
Flutiform - Article 29 referral - Annex I ES = español 25/10/2012  
Flutiform - Article 29 referral - Annex I CS = čeština 25/10/2012  
Flutiform - Article 29 referral - Annex I DA = dansk 25/10/2012  
Flutiform - Article 29 referral - Annex I DE = Deutsch 25/10/2012  
Flutiform - Article 29 referral - Annex I ET = eesti keel 25/10/2012  
Flutiform - Article 29 referral - Annex I EL = elliniká 25/10/2012  
Flutiform - Article 29 referral - Annex I EN = English 25/10/2012  
Flutiform - Article 29 referral - Annex I FR = français 25/10/2012  
Flutiform - Article 29 referral - Annex I IT = italiano 25/10/2012  
Flutiform - Article 29 referral - Annex I LV = latviešu valoda 25/10/2012  
Flutiform - Article 29 referral - Annex I LT = lietuvių kalba 25/10/2012  
Flutiform - Article 29 referral - Annex I HU = magyar 25/10/2012  
Flutiform - Article 29 referral - Annex I MT = Malti 25/10/2012  
Flutiform - Article 29 referral - Annex I NL = Nederlands 25/10/2012  
Flutiform - Article 29 referral - Annex I PL = polski 25/10/2012  
Flutiform - Article 29 referral - Annex I PT = português 25/10/2012  
Flutiform - Article 29 referral - Annex I RO = română 25/10/2012  
Flutiform - Article 29 referral - Annex I SK = slovenčina 25/10/2012  
Flutiform - Article 29 referral - Annex I SL = slovenščina 25/10/2012  
Flutiform - Article 29 referral - Annex I FI = suomi 25/10/2012  
Flutiform - Article 29 referral - Annex I SV = svenska 25/10/2012  
Flutiform - Article 29 referral - Annex I IS = Islenska 25/10/2012  
Flutiform - Article 29 referral - Annex I NO = Norsk 25/10/2012  
Flutiform - Article 29 referral - Annex II BG = bălgarski 25/10/2012  
Flutiform - Article 29 referral - Annex II ES = español 25/10/2012  
Flutiform - Article 29 referral - Annex II CS = čeština 25/10/2012  
Flutiform - Article 29 referral - Annex II DA = dansk 25/10/2012  
Flutiform - Article 29 referral - Annex II DE = Deutsch 25/10/2012  
Flutiform - Article 29 referral - Annex II ET = eesti keel 25/10/2012  
Flutiform - Article 29 referral - Annex II EL = elliniká 25/10/2012  
Flutiform - Article 29 referral - Annex II EN = English 25/10/2012  
Flutiform - Article 29 referral - Annex II FR = français 25/10/2012  
Flutiform - Article 29 referral - Annex II IT = italiano 25/10/2012  
Flutiform - Article 29 referral - Annex II LV = latviešu valoda 25/10/2012  
Flutiform - Article 29 referral - Annex II LT = lietuvių kalba 25/10/2012  
Flutiform - Article 29 referral - Annex II HU = magyar 25/10/2012  
Flutiform - Article 29 referral - Annex II MT = Malti 25/10/2012  
Flutiform - Article 29 referral - Annex II NL = Nederlands 25/10/2012  
Flutiform - Article 29 referral - Annex II PL = polski 25/10/2012  
Flutiform - Article 29 referral - Annex II PT = português 25/10/2012  
Flutiform - Article 29 referral - Annex II RO = română 25/10/2012  
Flutiform - Article 29 referral - Annex II SK = slovenčina 25/10/2012  
Flutiform - Article 29 referral - Annex II SL = slovenščina 25/10/2012  
Flutiform - Article 29 referral - Annex II FI = suomi 25/10/2012  
Flutiform - Article 29 referral - Annex II SV = svenska 25/10/2012  
Flutiform - Article 29 referral - Annex II IS = Islenska 25/10/2012  
Flutiform - Article 29 referral - Annex III BG = bălgarski 25/10/2012  
Flutiform - Article 29 referral - Annex III ES = español 25/10/2012  
Flutiform - Article 29 referral - Annex III CS = čeština 25/10/2012  
Flutiform - Article 29 referral - Annex III DA = dansk 25/10/2012  
Flutiform - Article 29 referral - Annex III DE = Deutsch 25/10/2012  
Flutiform - Article 29 referral - Annex III ET = eesti keel 25/10/2012  
Flutiform - Article 29 referral - Annex III EL = elliniká 25/10/2012  
Flutiform - Article 29 referral - Annex III EN = English 25/10/2012  
Flutiform - Article 29 referral - Annex III FR = français 25/10/2012  
Flutiform - Article 29 referral - Annex III IT = italiano 25/10/2012  
Flutiform - Article 29 referral - Annex III LV = latviešu valoda 25/10/2012  
Flutiform - Article 29 referral - Annex III LT = lietuvių kalba 25/10/2012  
Flutiform - Article 29 referral - Annex III HU = magyar 25/10/2012  
Flutiform - Article 29 referral - Annex III MT = Malti 25/10/2012  
Flutiform - Article 29 referral - Annex III NL = Nederlands 25/10/2012  
Flutiform - Article 29 referral - Annex III PL = polski 25/10/2012  
Flutiform - Article 29 referral - Annex III PT = português 25/10/2012  
Flutiform - Article 29 referral - Annex III RO = română 25/10/2012  
Flutiform - Article 29 referral - Annex III SK = slovenčina 25/10/2012  
Flutiform - Article 29 referral - Annex III SL = slovenščina 25/10/2012  
Flutiform - Article 29 referral - Annex III FI = suomi 25/10/2012  
Flutiform - Article 29 referral - Annex III SV = svenska 25/10/2012  
Flutiform - Article 29 referral - Annex III NO = Norsk 25/10/2012  

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 Flutiform