Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)
beclometasone / formoterol
Table of contents
Overview
Riarify is a medicine used in adults to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Riarify is used for maintenance (continuing) treatment in patients whose disease is not adequately controlled despite treatment with a combination of two COPD medicines consisting of a long-acting beta-2 agonist plus either an inhaled corticosteroid or a long-acting muscarinic receptor antagonist. Beta-2 agonists and muscarinic receptor antagonists help to widen the airways; corticosteroids reduce inflammation in the airways and lungs.
This medicine is the same as Trimbow, which is already authorised in the EU. The company that makes Trimbow has agreed that its scientific data can be used for Riarify (‘informed consent’).
Riarify contains the active substances beclometasone, formoterol and glycopyrronium bromide.
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Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.) : EPAR - Medicine overview (PDF/95.84 KB)
First published: 26/04/2018
Last updated: 06/09/2019
EMA/486960/2019 -
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Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.) : EPAR - Risk-management-plan summary (PDF/257.56 KB)
First published: 06/09/2019
Authorisation details
Product details | |
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Name |
Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)
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Agency product number |
EMEA/H/C/004836
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Pulmonary Disease, Chronic Obstructive
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Anatomical therapeutic chemical (ATC) code |
R03AL09
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Publication details | |
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Marketing-authorisation holder |
Chiesi Farmaceutici S.p.A.
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Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
23/04/2018
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Contact address |
Via Palermo 26/A |
Product information
09/12/2022 Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.) - EMEA/H/C/004836 - R/0022
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Drugs for obstructive airway diseases
Therapeutic 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).