Salmeterol and Fluticasone Propionate

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

The fixed combination medicinal product formulated as inhalation powder, pre-dispensed consisting of salmeterol (50μg), a long-acting beta-2-adrenoceptor agonist, and fluticasone propionate (FP 100μg, 250μg, or 500μg), a corticosteroid, was first authorised in Sweden for the regular treatment of asthma where use of a combination (long-acting beta agonist and inhaled corticosteroid) is appropriate. It was subsequently licensed via a Mutual Recognition Procedure (MRP) in December 1998 with Sweden as Reference Member State (RMS); the Concerned Member States were Austria, Belgium, Germany, Denmark, Greece, Spain, Finland, France, Ireland, Italy, Luxembourg, Portugal, the Netherlands and United Kingdom.

In September 2001, the Marketing Authorisation Holders (MAHs) applied for a Type II variation through MRP to include chronic obstructive pulmonary disease (COPD) as a therapeutic indication for the fixed-dose combination of salmeterol/FP 50/500 μg twice daily. The RMS reached a negative view on use in COPD even after the proposed treatment population was restricted to patients with moderate to severe COPD as indicated by an FEV1 of 50% or less of predicted normal.

The separate components of the salmeterol/FP combination are not approved for use in the treatment of chronic obstructive pulmonary disease (COPD) in all EU Member States.

On 19 April 2002, Ireland via the Irish Medicines Board (IMB) triggered a referral to the EMEA under Article 7(5) of Commission Regulation (EC) No 541/95. The IMB believed that having both components as a fixed dose combination could represent a convenience and compliance advantage to patients suffering from this common condition (i.e. COPD), as is recognised in the CPMP Note for Guidance for Fixed Combination Medicinal Products (section 1.2.b – a simplification of therapy). Moreover, the IMB considered that this aspect has not been sufficiently taken into consideration when the RMS, reached its opinion that the clinical benefit of the combination was marginal and that the efficacy advantage of the combination had not been convincingly demonstrated with respect to that of the separate components. The IMB therefore requested the CPMP to give an opinion on the scope of this variation application, i.e. the indication of treatment of COPD.

The referral procedure started on 26 April 2002. The Rapporteur and Co-Rapporteur appointed were: Dr. D. Lyons and Dr. P. Arlett, respectively. Written explanations were provided by the MAHs on 13 August 2002. Supplementary information was provided by the MAHs on 16 December 2002. Oral explanations were given by MAHs on 21 January 2003.

Based on re-evaluation of the currently available information on the above-concerned medicinal products, the CPMP considered that overall the balance of risks and benefits of the above-concerned medicinal product is favourable for the new restricted indication, and therefore adopted by majority an opinion on 23 January 2003 recommending the granting of the variation of the Marketing Authorisations for the fixed combination medicinal products containing salmeterol and fluticasone propionate for the indication of “the symptomatic treatment of patients with severe COPD (FEV1 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy” and the amendment of the summary of product characteristics.

The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II together with the amended Summary of Product Characteristics in the Annex III.

The final opinion was converted into a Decision by the European Commission on 21 May 2003.

Key facts

Approved name
Salmeterol and Fluticasone Propionate
International non-proprietary name (INN) or common name
  • salmeterol
  • fluticasone
Class
-
Reference number
Salmeterol and fluticasone
Type
Article 6(12) referrals (prior to January 2010)

This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation (type II). This referral has been replaced by Article 13 referrals.

Status
European Commission final decision
Opinion date
24/01/2003
EC decision date
21/05/2003

All documents

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.

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