Article Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. STATEMENT OF ACTIVE SUBSTANCE(S)
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
- 7. OTHER SPECIAL WARNING(S), IF NECESSARY
- 8. EXPIRY DATE
- 9. SPECIAL STORAGE CONDITIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 14. GENERAL CLASSIFICATION FOR SUPPLY
- 15. INSTRUCTIONS ON USE
- 16. INFORMATION IN BRAILLE
- 17. UNIQUE IDENTIFIER – 2D BARCODE
- 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
- 2. NAME OF THE MARKETING AUTHORISATION HOLDER
- 3. EXPIRY DATE
- 4. BATCH NUMBER
- 5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Maintenance pack
Heat sealed card pack containing either 2 blister packs of 14 x 0.5 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 0.5 mg
Varenicline
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 0.5 mg varenicline (as tartrate).
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
Maintenance pack containing 28
56
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use numbers 1 to 14
numbers 1 to 28 sun as symbol moon as symbol
Do not use if box has been opened.
Keep the package intact
6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE
9.SPECIAL STORAGE CONDITIONS
Store below 30°C
10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/06/360/006
EU/1/06/360/007
EU/1/06/360/017
EU/1/06/360/018
13.BATCH NUMBER
Lot:
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
CHAMPIX 0.5 mg
17.UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister Pack of 14 x 0.5 mg and 28 x 0.5 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 0.5 mg
Varenicline
2.NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer Ltd (as MA Holder Logo)
3.EXPIRY DATE
4.BATCH NUMBER
Lot:
5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Maintenance pack
Heat sealed card pack containing either 2 blister packs of 14 x 1 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 1 mg
Varenicline
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 1 mg varenicline (as tartrate).
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
Maintenance pack containing 28
56
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use numbers 1 to 14
numbers 1 to 28 sun as symbol moon as symbol
Do not use if box has been opened.
Keep the package intact
6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE
9.SPECIAL STORAGE CONDITIONS
Store below 30°C
10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/06/360/004
EU/1/06/360/005
EU/1/06/360/015
EU/1/06/360/016
13.BATCH NUMBER
Lot:
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
CHAMPIX 1 mg
17.UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister Pack of 14 x 1 mg and 28 x 1 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 1 mg
Varenicline
2.NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer Ltd (as MA Holder Logo)
3.EXPIRY DATE
4.BATCH NUMBER
Lot:
5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Maintenance pack
Carton Pack containing 2 blister packs of 14 x 1 mg varenicline packs of 14 x 1 mg varenicline
packs of 14 x 1 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 1 mg
Varenicline
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 1 mg varenicline (as tartrate).
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
28
56
112
140
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
Do not use if box has been opened.
6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.OTHER SPECIAL WARNING(S), IF NECESSARY
8.EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS
Store below 30°C
10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/06/360/009
EU/1/06/360/010
EU/1/06/360/011
EU/1/06/360/013
EU/1/06/360/020
EU/1/06/360/021
EU/1/06/360/022
EU/1/06/360/024
13.BATCH NUMBER
Lot:
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
CHAMPIX 1 mg
17.UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister Pack of 14 x 1 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 1 mg
Varenicline
2.NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer Ltd (as MA Holder Logo)
3.EXPIRY DATE
4.BATCH NUMBER
Lot:
5.OTHER
sun as symbol moon as symbol

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 0.5 mg
CHAMPIX 1 mg
Varenicline
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 0.5 mg or 1 mg varenicline (as tartrate).
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
Initiation pack containing
11 x 0.5 mg and 14 x 1 mg
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
Start at day 1
The day you stop smoking should usually be between day 8 and day 14.
To quit gradually, please refer to package leaflet for dosing instructions.
Week 1
Week 2
Numbers 1 to 14 sun as symbol moon as symbol
Do not use if box has been opened.
Keep the package intact
Does not contain a tablet

6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.OTHER SPECIAL WARNING(S), IF NECESSARY
8.EXPIRY DATE
9.SPECIAL STORAGE CONDITIONS
Store below 30°C
10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/06/360/003
EU/1/06/360/014
13.BATCH NUMBER
Lot:
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE
CHAMPIX 0.5 mg
1 mg
17.UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18.UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister Pack of 11 x 0.5 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 0.5 mg
Varenicline
2.NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer Ltd (as MA Holder Logo)
3.EXPIRY DATE
EXP
4.BATCH NUMBER
Lot
5.OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister Pack of 14 x 1 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 1 mg
Varenicline
2.NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer Ltd (as MA Holder Logo)
3.EXPIRY DATE
EXP
4.BATCH NUMBER
Lot
5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Treatment initiation pack
Carton pack with 1 blister pack of 11 x 0.5 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 0.5 mg
CHAMPIX 1 mg
Varenicline
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 0.5 mg or 1 mg varenicline (as tartrate).
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
11 x 0.5 mg and 14 x 1 mg
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
- Besponsa - Pfizer Limited
- Rapamune - Pfizer Limited
- Duavive - Pfizer Limited
- Onsenal - Pfizer Limited
- Toviaz - Pfizer Limited
- Pregabalin pfizer - Pfizer Limited
Prescription drugs listed. Manufacturer: "Pfizer Limited"
Do not use if box has been opened.
6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.OTHER SPECIAL WARNING(S), IF NECESSARY
8.EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS
Store below 30°C
10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/06/360/008
EU/1/06/360/019
13.BATCH NUMBER
Lot
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
CHAMPIX 0.5 mg
1 mg
17.UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister Pack of 11 x 0.5 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 0.5 mg
Varenicline
2.NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer Ltd (as MA Holder Logo)
3.EXPIRY DATE
4.BATCH NUMBER
Lot:
5.OTHER
sun as symbol moon as symbol

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister Pack of 14 x 1 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 1 mg
Varenicline
2.NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer Ltd (as MA Holder Logo)
3.EXPIRY DATE
4.BATCH NUMBER
Lot:
5.OTHER
sun as symbol moon as symbol

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 0.5 mg
CHAMPIX 1 mg
Varenicline
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 0.5 mg or 1 mg varenicline (as tartrate).
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
11 x 0.5 mg
42 x 1 mg
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
Start at Day 1
The day you stop smoking should usually be between day 8 and day 14.
To quit gradually, please refer to package leaflet for dosing instructions.
Week 1
Numbers 1 to 28 sun as symbol moon as symbol
Do not use if box has been opened.
Keep the package intact
Does not contain any tablets

6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.OTHER SPECIAL WARNING(S), IF NECESSARY
8.EXPIRY DATE
9.SPECIAL STORAGE CONDITIONS
Store below 30°C
10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/06/360/012
EU/1/06/360/023
13.BATCH NUMBER
Lot:
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE
CHAMPIX 0.5 mg
1 mg
17.UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18.UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister Pack of 11 x 0.5 mg and 14 x 1 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 0.5 mg
CHAMPIX 1 mg
Varenicline
2.NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer Ltd (as MA Holder Logo)
3.EXPIRY DATE
4.BATCH NUMBER
Lot:
5.OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister Pack of 28 x 1 mg varenicline
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 1 mg
Varenicline
2.NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer Ltd (as MA Holder Logo)
3.EXPIRY DATE
4.BATCH NUMBER
Lot:
5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 0.5 mg
Varenicline
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 0.5 mg varenicline (as tartrate).
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
56
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.OTHER SPECIAL WARNING(S), IF NECESSARY
8.EXPIRY DATE
9.SPECIAL STORAGE CONDITIONS
10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/06/360/001
13.BATCH NUMBER
Lot:
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
CHAMPIX 0.5 mg
17.UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18.UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:

PARTICULARS TO APPEAR ON THE THE IMMEDIATE PACKAGING
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 0.5 mg
Varenicline
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 0.5 mg varenicline (as tartrate).
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
56
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.OTHER SPECIAL WARNING(S), IF NECESSARY
8.EXPIRY DATE
9.SPECIAL STORAGE CONDITIONS
10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Ltd (as MA Holder Logo)
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/06/360/001
13.BATCH NUMBER
Lot:
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
17.UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18.UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 1 mg
Varenicline
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 1 mg varenicline (as tartrate).
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
56
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.OTHER SPECIAL WARNING(S), IF NECESSARY
8.EXPIRY DATE
9.SPECIAL STORAGE CONDITIONS
10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/06/360/002
13.BATCH NUMBER
Lot:
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
CHAMPIX 1 mg
17.UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18.UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:

PARTICULARS TO APPEAR ON THE THE IMMEDIATE PACKAGING
1.NAME OF THE MEDICINAL PRODUCT
CHAMPIX 1 mg
Varenicline
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 1 mg varenicline (as tartrate).
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
56
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.OTHER SPECIAL WARNING(S), IF NECESSARY
8.EXPIRY DATE
9.SPECIAL STORAGE CONDITIONS
10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Ltd (as MA Holder Logo)
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/06/360/002
13.BATCH NUMBER
Lot:
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
17.UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18.UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN:
Comments