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Libertek

Active Substance: roflumilast
Common Name: roflumilast
ATC Code: R03DX08
Marketing Authorisation Holder: AstraZeneca AB
Active Substance: roflumilast
Status: Withdrawn
Authorisation Date: 2011-02-28
Therapeutic Area: Pulmonary Disease, Chronic Obstructive
Pharmacotherapeutic Group: Drugs for obstructive airway diseases

Therapeutic 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.

The marketing authorisation for Libertek has been withdrawn at the request of the marketing-authorisation holder.

Source: European Medicines Agency

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