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Champix (varenicline) – Labelling - N07BA03

Updated on site: 05-Oct-2017

Medication nameChampix
ATC CodeN07BA03
Substancevarenicline
ManufacturerPfizer Limited

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 film-coated tablets or 2 blister packs of 28 x 0.5 mg varenicline film-coated tablets– inner and outer labelling

1.NAME OF THE MEDICINAL PRODUCT

CHAMPIX 0.5 mg

Film-coated tablets

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 film-coated tablets

56 film-coated tablets

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 film-coated tablets, Heat Sealed Card

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 film-coated tablets or 2 blister packs of 28 x 1 mg varenicline film-coated tablets– inner and outer labelling

1.NAME OF THE MEDICINAL PRODUCT

CHAMPIX 1 mg

Film-coated tablets

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 film-coated tablets

56 film-coated tablets

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 film-coated tablets, Heat Sealed Card

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 film-coated tablets or 4 blister packs of 14 x 1 mg varenicline film-coated tablets or 8 blisterpacks of 14 x 1 mg varenicline film-coated tablets or 10 blisterpacks of 14 x 1 mg varenicline film-coated tablets

1.NAME OF THE MEDICINAL PRODUCT

CHAMPIX 1 mg

Film-coated tablets

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 Film-coated tablets

56 Film-coated tablets

112 Film-coated tablets

140 Film-coated tablets

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 film-coated tablets

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

2-week treatment initiation pack

Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg varenicline film-coated tablets and 1 blister pack of 14 x 1 mg varenicline film-coated tablets – inner and outer labelling

1.NAME OF THE MEDICINAL PRODUCT

CHAMPIX 0.5 mg

CHAMPIX 1 mg

Film-coated tablets

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 Film-coated tablets

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 film-coated tablets, Heat Sealed Card

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 film-coated tablets, Heat Sealed Card

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 film-coated tablets and 1 blister pack of 14 x 1 mg varenicline film-coated tablets

1.NAME OF THE MEDICINAL PRODUCT

CHAMPIX 0.5 mg

CHAMPIX 1 mg

Film-coated tablets

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

Film-coated tablets

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.

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 film-coated tablets

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 film-coated tablets

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

4-week treatment initiation pack

Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 x 1 mg varenicline film-coated tablets – inner and outer labelling

1.NAME OF THE MEDICINAL PRODUCT

CHAMPIX 0.5 mg

CHAMPIX 1 mg

Film-coated tablets

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

4-week treatment initiation pack containing:

11 x 0.5 mg film-coated tablets and

42 x 1 mg film-coated tablets

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 film-coated tablets, Heat Sealed Card

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 film-coated tablets, Heat Sealed Card

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

High-density polyethylene (HDPE) bottle packaging for 56 x 0.5 mg varenicline film-coated tablets

1.NAME OF THE MEDICINAL PRODUCT

CHAMPIX 0.5 mg

Film-coated tablets

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 Film-coated tablets

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

High-density polyethylene (HDPE) bottle label for 56 x 0.5 mg varenicline film-coated tablets

1.NAME OF THE MEDICINAL PRODUCT

CHAMPIX 0.5 mg

Film-coated tablets

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 Film-coated tablets

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

High-density polyethylene (HDPE) bottle packaging for 56 x 1 mg varenicline film-coated tablets

1.NAME OF THE MEDICINAL PRODUCT

CHAMPIX 1 mg

Film-coated tablets

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 Film-coated tablets

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

High-density polyethylene (HDPE) bottle label for 56 x 1 mg varenicline film-coated tablets

1.NAME OF THE MEDICINAL PRODUCT

CHAMPIX 1 mg

Film-coated tablets

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 Film-coated tablets

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:

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