- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Seretide Diskus and associated names (see Annex I) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting beta-agonist salmeterol and the inhaled corticosteroid fluticasone propionate and is indicated for the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
In several EU Member States Seretide Diskus and associated names are approved through the Mutual Recognition Procedure (MRP). In the MRP Sweden is the Reference Member State (RMS) and Austria, Belgium, Denmark, Finland, France, Greece, Germany, Italy, Ireland, Luxembourg, The Netherlands, Portugal, Spain and the United Kingdom are Concerned Member States (CMS).
The Marketing Authorisation Holders submitted a type II variation subject to the MRP in July 2004 to extend the indication to include initial maintenance therapy with the fixed dose combination in patients with chronic persistent asthma. The RMS and CMSs rejected the type II variation based on the grounds that the overall risk/benefit was unfavourable for the initial maintenance therapy indication.
On 12 August 2005 the Marketing Authorisation Holders presented to the EMEA a referral under article 6(13) of Commission Regulation (EC) No 1084/2003. On the basis of the grounds for referral, the point considered by the CHMP was whether it is appropriate to introduce initial maintenance therapy with the fixed dose combination of salmeterol and fluticasone propionate in all patients with chronic persistent asthma.
The referral procedure started on 19 September 2005. The Rapporteur and Co-Rapporteur appointed were Dr D Lyons and Dr G Calvo Rojas, respectively. Supplementary information was provided by the Marketing Authorisation Holders on 3 February 2006 and written explanations were given on 30 March 2006.
Based on evaluation of the available data and the Rapporteur's assessment reports, the CHMP adopted an opinion on 27 April 2006 recommending the variation to the terms of the Marketing Authorisations with amendments to the Summary of Product Characteristics, Labelling and Package leaflet.
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, Labelling and Package Leaflet in the Annex III.
The final opinion was converted into a Decision by the European Commission on 4 July 2006.
Summary information on referral opinion pursuant to Article 6(13) of Commission Regulation (EC) No 1084/2003 for Seretide Diskus and associated names (See Annex I) International Non-Proprietary Name (INN): salmeterol / f... (PDF/34.07 KB)Adopted
First published: 04/07/2006
Last updated: 04/07/2006
About this medicine
|International non-proprietary name (INN) or common name||
About this procedure
European Commission final decision
Article 6(13) referrals (prior to January 2010)
This type of referral was triggered by the marketing-authorisation holder for a medicine that had been authorised by mutual recognition or via the decentralised procedure when Member States could not accept the variation (type II).
Key dates and outcomes
|CHMP opinion date||
|EC decision date||
Summary information on referral opinion pursuant to Article 6(13) of Commission Regulation (EC) No 1084/2003 for Seretide Diskus and associated names (See Annex I) International Non-Proprietary Name (INN): salmeterol / f... (PDF/34.07 KB)
First published: 04/07/2006
Last updated: 04/07/2006
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.