Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)
Withdrawn
This medicine's authorisation has been withdrawn
beclometasone / formoterol
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 6 March 2025 the European Commission withdrew the marketing authorisation for Riarify (beclometasone / formoterol / glycopyrronium bromide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Chiesi Farmaceutici S.p.A., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Riarify was granted marketing authorisation in the EU on 23 April 2018 for the symptomatic treatment and reduction of exacerbations in adult patients with chronic obstructive pulmonary disease (COPD) with airflow limitation and who are at risk of exacerbations. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2022.
Riarify was only marketed in Ireland and was a duplicate of another medicine called Trimbow, which remains available to patients in the EU.
The European public assessment report (EPAR) for Riarify will be updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
N/0034
04/11/2024
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
- Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)
- Active substance
- formoterol fumarate dihydrate
- glycopyrronium
- Beclometasone dipropionate
- International non-proprietary name (INN) or common name
- beclometasone
- formoterol
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03AL09
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptoms control and prevention of exacerbations see section 5.1).
News on Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)
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