Champix
varenicline
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Champix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Champix.
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List item
Champix : EPAR - Summary for the public (PDF/86.46 KB)
First published: 11/10/2006
Last updated: 03/04/2014 -
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List item
Champix : EPAR - Risk-management-plan summary (PDF/198.81 KB)
First published: 02/07/2019
Authorisation details
Product details | |
---|---|
Name |
Champix
|
Agency product number |
EMEA/H/C/000699
|
Active substance |
varenicline
|
International non-proprietary name (INN) or common name |
varenicline
|
Therapeutic area (MeSH) |
Tobacco Use Cessation
|
Anatomical therapeutic chemical (ATC) code |
N07BA03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
37
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Date of issue of marketing authorisation valid throughout the European Union |
25/09/2006
|
Contact address |
Boulevard de la Plaine 17 |
Product information
21/09/2021 Champix - EMEA/H/C/000699 - N/0081
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
Other nervous system drugs
Therapeutic indication
Champix is indicated for smoking cessation in adults.