Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
CHAMPIX 0.5 mg film-coated tablets.
CHAMPIX 1 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets. 0.5 mg film-coated tablets of 4 mm x 8 mm: White, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 0.5” on the other side. 1 mg film-coated tablets of 5 mm x 10 mm: Light blue, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 1.0” on the other side. |
Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as tartrate).
Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Varenicline |
Varenicline binds with high affinity and selectivity at the α4β2 neuronal nicotinic acetylcholine receptors, where it acts as a partial agonist – a compound that has both agonist activity, with lower intrinsic efficacy than nicotine, and antagonist activities in the presence of nicotine. |
| List of Excipients |
|---|
|
Tablets' core: 0.5 mg and 1 mg Tablets: Cellulose, microcrystalline Film coating: 0.5 mg Tablet: Hypromellose 1 mg Tablet: Hypromellose |
Treatment initiation packs:
PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 × 0.5 mg film-coated tablets and a second clear blister of 14 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 × 0.5 mg film-coated tablets and a second clear blister containing 14 × 1 mg film-coated tablets in a carton.
PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 × 0.5 mg and 14 × 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PVC blisters with aluminium foil backing containing 1 clear blister of 11 × 0.5 mg film-coated tablets and a second clear blister of 14 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PVC blisters with aluminium foil backing containing 1 clear blister of 11 × 0.5 mg film-coated tablets and a second clear blister containing 14 × 1 mg film-coated tablets in a carton.
PVC blisters with aluminium foil backing containing 1 clear blister of 11 × 0.5 mg and 14 × 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 × 1 mg film-coated tablets in secondary heat sealed card packaging.
One outer carton containing:
PCTFE/PVC blisters with aluminium foil backing containing one clear blister of 11 × 0.5 mg and 14 × 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 × 1 mg film-coated tablets in one secondary heat sealed card pack and PCTFE/PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 × 1 mg film-coated tablets.
One outer carton containing:
PVC blisters with aluminium foil backing containing one clear blister of 11 × 0.5 mg and 14 × 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 × 1 mg film-coated tablets in one secondary heat sealed card pack and PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 × 1 mg film-coated tablets.
Maintenance packs:
PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 × 0.5 mg film-coated tablets in secondary heat sealed card packaging.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 × 0.5 mg film-coated tablets in secondary heat sealed card packaging.
PVC blisters with aluminium foil backing in a pack containing 28 × 0.5 mg film-coated tablets in secondary heat sealed card packaging.
PVC blisters with aluminium foil backing in a pack containing 56 × 0.5 mg film-coated tablets in secondary heat sealed card packaging.
High-density polyethylene (HDPE) bottle with polypropylene child resistant closure and an aluminium foil /polyethylene induction seal containing 56 × 0.5 mg film-coated tablets
PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 × 1 mg film-coated tablets in a carton.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 × 1 mg film-coated tablets in a carton.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 112 × 1 mg film-coated tablets in a carton.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 140 × 1 mg film-coated tablets in a carton.
PVC blisters with aluminium foil backing in a pack containing 28 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PVC blisters with aluminium foil backing in a pack containing 56 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PVC blisters with aluminium foil backing in a pack containing 28 × 1 mg film-coated tablets in a carton.
PVC blisters with aluminium foil backing in a pack containing 56 × 1 mg film-coated tablets in a carton.
PVC blisters with aluminium foil backing in a pack containing 112 × 1 mg film-coated tablets in a carton.
PVC blisters with aluminium foil backing in a pack containing 140 × 1 mg film-coated tablets in a carton.
High-density polyethylene (HDPE) bottle with polypropylene child resistant closure and an aluminium foil/polyethylene induction seal containing 56 × 1 mg film-coated tablets
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
0.5 mg tablets:
EU/1/06/360/001
EU/1/06/360/006
EU/1/06/360/007
EU/1/06/360/017
EU/1/06/360/018
1mg tablets:
EU/1/06/360/002
EU/1/06/360/004
EU/1/06/360/005
EU/1/06/360/009
EU/1/06/360/010
EU/1/06/360/011
EU/1/06/360/013
EU/1/06/360/015
EU/1/06/360/016
EU/1/06/360/020
EU/1/06/360/021
EU/1/06/360/022
EU/1/06/360/024
Treatment initiation packs:
EU/1/06/360/003
EU/1/06/360/008
EU/1/06/360/012
EU/1/06/360/014
EU/1/06/360/019
EU/1/06/360/023
EU/1/06/360/025
EU/1/06/360/026
Date of first authorisation: 26 September 2006
Date of latest renewal: 29 June 2016
| Drug | Countries | |
|---|---|---|
| CHAMPIX | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa |
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