🇪🇺 Beclometasone in European Union

EMA authorised Beclometasone on 23 April 2018

Marketing authorisations

EMA — authorised 23 April 2018

  • Application: EMEA/H/C/004836
  • Marketing authorisation holder: Chiesi Farmaceutici S.p.A.
  • Local brand name: Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)
  • 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).
  • Status: withdrawn

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EMA — authorised 26 April 2018

  • Application: EMEA/H/C/004702
  • Marketing authorisation holder: Chiesi Farmaceutici S.p.A.
  • Local brand name: Trydonis
  • 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).
  • Status: approved

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Beclometasone in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Respiratory approved in European Union

Frequently asked questions

Is Beclometasone approved in European Union?

Yes. EMA authorised it on 23 April 2018; EMA authorised it on 26 April 2018.

Who is the marketing authorisation holder for Beclometasone in European Union?

Chiesi Farmaceutici S.p.A. holds the EU marketing authorisation.