Alisade
Lapsed
This medicine's authorisation has lapsed
fluticasone furoate
MedicineHumanLapsed
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 6 October 2008, the European Commission granted a marketing authorisation valid throughout the European Union (EU) for the medicinal product Alisade (fluticasone furoate), indicated for use in the treatment of the symptoms of allergic rhinitis. The marketing authorisation holder was notified on the 8 October 2008.
Alisade (fluticasone furoate) had not been marketed in Europe since this initial marketing authorisation. In accordance with article 14(4) of Regulation (EC) No 726/2004 ('sunset clause'), the marketing authorisation of a medicinal product lapses if the product has never been marketed in one of the Member States within three years of its initial authorisation.
Because of this, from 9 October 2011, the marketing authorisation for Alisade is no longer valid. Avamys (fluticasone furoate) is an identical product authorised in the EU to treat the symptoms of allergic rhinitis. Pursuant to the expiry of the marketing authorisation, the European Assessment Report (EPAR) for Alisade is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IB/0007
17/02/2010
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Alisade
- Active substance
- fluticasone furoate
- International non-proprietary name (INN) or common name
- fluticasone furoate
- Therapeutic area (MeSH)
- Rhinitis, Allergic, Perennial
- Rhinitis, Allergic, Seasonal
- Anatomical therapeutic chemical (ATC) code
- R01AD12
Pharmacotherapeutic group
Nasal preparationsTherapeutic indication
Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.
Assessment history
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