Libertek
roflumilast
Table of contents
Overview
The marketing authorisation for Libertek has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Libertek
|
| Agency product number |
EMEA/H/C/002399
|
| 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
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
AstraZeneca AB
|
| Revision |
11
|
| Date of issue of marketing authorisation valid throughout the European Union |
28/02/2011
|
| Contact address |
151 85 Sodertalje |
Product information
11/01/2018 Libertek - EMEA/H/C/002399 - T/0031
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.