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.
Champix : EPAR - Summary for the public (PDF/86.46 KB)
First published: 11/10/2006
Last updated: 03/04/2014
Champix : EPAR - Risk-management-plan summary (PDF/198.81 KB)
First published: 02/07/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Tobacco Use Cessation
|Anatomical therapeutic chemical (ATC) code||
Pfizer Europe MA EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
16/05/2019 Champix - EMEA/H/C/000699 - II/0074
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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Other nervous system drugs
Champix is indicated for smoking cessation in adults.