🇪🇺 GLYCOPYRRONIUM in European Union

EMA authorised GLYCOPYRRONIUM on 6 January 2022

Marketing authorisation

EMA — authorised 6 January 2022

  • Application: EMEA/H/C/005311
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Riltrava Aerosphere
  • 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).
  • Status: approved

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GLYCOPYRRONIUM in other countries

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

Frequently asked questions

Is GLYCOPYRRONIUM approved in European Union?

Yes. EMA authorised it on 6 January 2022.

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

AstraZeneca AB holds the EU marketing authorisation.