🇪🇺 Roflumilast conventional dosage in European Union

EMA authorised Roflumilast conventional dosage on 5 July 2010

Marketing authorisation

EMA — authorised 5 July 2010

  • Application: EMEA/H/C/001179
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Daxas
  • Indication: Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.
  • Status: approved

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Other Respiratory / Pulmonology approved in European Union

Frequently asked questions

Is Roflumilast conventional dosage approved in European Union?

Yes. EMA authorised it on 5 July 2010.

Who is the marketing authorisation holder for Roflumilast conventional dosage in European Union?

AstraZeneca AB holds the EU marketing authorisation.