Riltrava Aerosphere
formoterol fumarate dihydrate / glycopyrronium / budesonide
Table of contents
Overview
Riltrava Aerosphere is a medicine used to treat patients with moderate to severe chronic obstructive pulmonary disease (COPD), a long-term disease in which the airways and air sacs in the lungs become damaged or blocked, leading to difficulty breathing.
Riltrava Aerosphere is used for maintenance (regular) treatment in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a long-acting muscarinic antagonist.
Riltrava Aerosphere contains the active substances formoterol, glycopyrronium bromide and budesonide.
This medicine is the same as Trixeo Aerosphere, which is already authorised in the EU. The company that makes Trixeo Aerosphere has agreed that its scientific data can be used for Riltrava Aerosphere (‘informed consent’).
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Riltrava Aerosphere : EPAR - Medicine Overview (PDF/126.61 KB)
First published: 04/02/2022
EMA/697663/2021 -
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Riltrava Aerosphere : EPAR - Risk management plan summary (PDF/158.47 KB)
First published: 04/02/2022
Authorisation details
Product details | |
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Name |
Riltrava Aerosphere
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Agency product number |
EMEA/H/C/005311
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Active substance |
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International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Pulmonary Disease, Chronic Obstructive
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Anatomical therapeutic chemical (ATC) code |
R03AL11
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Publication details | |
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Marketing-authorisation holder |
AstraZeneca AB
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Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
06/01/2022
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Contact address |
AstraZeneca AB |
Product information
19/05/2022 Riltrava Aerosphere - EMEA/H/C/005311 - IA/0001
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
Riltrava Aerosphere is indicated as a 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 or combination of a long-acting beta2 agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1).