Champix

RSS

varenicline

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 07/08/2018

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
32
Date of issue of marketing authorisation valid throughout the European Union
26/09/2006
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

30/07/2018 Champix - EMEA/H/C/000699 - T/0071

Contents

  • 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.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

OTHER NERVOUS SYSTEM DRUGS

Therapeutic indication

Champix is indicated for smoking cessation in adults.

Assessment history

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