Flutiform - referral

Current status

European Commission final decision

Overview

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.

Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension)

AdoptedReference Number: EMA/264710/2012Summary:

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.

Key facts

About this medicine

• Approved name:
  Flutiform
• International non-proprietary name (INN) or common name:
  • fluticasone propionate
  • formoterol fumarate
• Associated names:
  • Iffeza
  • Flofera
  • Flutiformo

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/001326
• 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.

Key dates and outcomes

• CHMP opinion date:
  19/04/2012
• EC decision date:
  28/06/2012

All documents

European Commission final decision

Flutiform - Article 29 referral - Assessment report

Reference Number: EMA/399193/2012

Flutiform - Article 29 referral - Annex I

Flutiform - Article 29 referral - Annex II

Flutiform - Article 29 referral - Annex III

Questions and answers on Flutiform and Iffeza (fluticasone propionate / formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension)

AdoptedReference Number: EMA/264710/2012Summary:

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.

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.