Trydonis

beclometasone / formoterol / glycopyrronium bromide

Opinion

On 28 February 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Trydonis. The marketing authorisation holder for this medicinal product is Chiesi Farmaceutici S.p.A.

The CHMP adopted an extension to the existing indication as follows:

“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 a 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)”.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


* New text in bold

Key facts

Name
Trydonis
Agency product number
EMEA/H/C/004702
International non-proprietary name (INN) or common name
  • beclometasone / formoterol / glycopyrronium bromide
Active substance
  • Beclometasone dipropionate
  • formoterol fumarate dihydrate
  • glycopyrronium
Therapeutic area
Pulmonary Disease, Chronic Obstructive
Date opinion adopted
28/02/2019
Company name
Chiesi Farmaceutici S.p.A.
Status
Positive
Application type
Post-authorisation

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