Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)

Withdrawn

This medicine's authorisation has been withdrawn

beclometasone / formoterol

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European public assessment report (EPAR) for Riarify will be updated to indicate that the marketing authorisation is no longer valid.

Riarify : EPAR - Medicine overview

Reference Number: EMA/486960/2019

Riarify : EPAR - Risk-management-plan summary

Product information

Riarify : EPAR - Product Information

Riarify : EPAR - All Authorised presentations

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 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).

Authorisation details

• EMA product number:
  EMEA/H/C/004836
• Marketing authorisation holder:
  Chiesi Farmaceutici S.p.A.

  Via Palermo 26/A; 43122 Parma; Italy

• Opinion adopted:
  22/02/2018
• Marketing authorisation issued:
  23/04/2018
• Withdrawal of marketing authorisation:
  06/03/2025
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

Riarify : EPAR - Procedural steps taken and scientific information after authorisation

Riarify-H-C-4836 : EPAR - Assessment Report - Variation

CHMP post-authorisation summary of positive opinion for Riarify

Adopted Reference Number: EMA/CHMP/136909/2019

Initial marketing authorisation documents

Riarify : EPAR - Public assessment report

Adopted Reference Number: EMA/155339/2018

CHMP summary of positive opinion for Riarify

Adopted Reference Number: EMA/CHMP/109090/2018 Rev. 1