Libertek
Withdrawn
This medicine's authorisation has been withdrawn
roflumilast
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 11 January 2018, the European Commission withdrew the marketing authorisation for Libertek (roflumilast) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AstraZeneca AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Libertek was granted marketing authorisation in the EU on 28 February 2011 for treatment of chronic obstructive pulmonary disease (COPD). The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period.
Libertek was a duplicate of Daxas, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Daxas.
The European Public Assessment Report (EPAR) for Libertek is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:T/0031
11/01/2018
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Libertek
- Active substance
- roflumilast
- International non-proprietary name (INN) or common name
- roflumilast
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03DX08
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic 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.
Assessment history
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