EMA — authorised 28 February 2011
- Status: approved
🇪🇺 Daliresp in European Union
EMA authorised Daliresp on 28 February 2011
Marketing authorisations
EMA — authorised 28 February 2011
- Application: EMEA/H/C/002399
- Marketing authorisation holder: AstraZeneca AB
- Local brand name: Libertek
- Indication: Libertek 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- Status: withdrawn
Daliresp in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in European Union
Frequently asked questions
Is Daliresp approved in European Union?
Yes. EMA authorised it on 28 February 2011; EMA authorised it on 28 February 2011.
Who is the marketing authorisation holder for Daliresp in European Union?
Arcutis is the originator. The local marketing authorisation holder may differ — check the official source linked above.