Sutent (sunitinib) – Labelling - L01XE04

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

HDPE BOTTLE OUTER CARTON - 12.5 MG CAPSULES

1.NAME OF THE MEDICINAL PRODUCT

Sutent 12.5 mg hard capsules sunitinib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

30hard capsules

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

EXP

9.SPECIAL STORAGE CONDITIONS

This medicinal product does not require any special storage conditions.

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS HDPE BOTTLE – 12.5 MG CAPSULES

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Sutent 12.5 mg hard capsules sunitinib

Oral use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30capsules

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

HDPE BOTTLE OUTER CARTON - 25 MG CAPSULES

1.NAME OF THE MEDICINAL PRODUCT

Sutent 25 mg hard capsules sunitinib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

30hard capsules

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

EXP

9.SPECIAL STORAGE CONDITIONS

This medicinal product does not require any special storage conditions.

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS HDPE BOTTLE – 25 MG CAPSULES

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Sutent 25 mg hard capsules sunitinib

Oral use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30capsules

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS HDPE BOTTLE – 37.5 MG CAPSULES

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Sutent 37.5 mg hard capsules sunitinib

Oral use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30capsules

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

HDPE BOTTLE OUTER CARTON - 50 MG CAPSULES

1.NAME OF THE MEDICINAL PRODUCT

Sutent 50 mg hard capsules sunitinib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

30hard capsules

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

EXP

9.SPECIAL STORAGE CONDITIONS

This medicinal product does not require any 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

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/347/003

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Sutent 50 mg

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS HDPE BOTTLE – 50 MG CAPSULES

1.NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Sutent 50 mg hard capsules sunitinib

Oral use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30capsules

6.OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER – 12.5 MG CAPSULES

1. NAME OF THE MEDICINAL PRODUCT

Sutent 12.5 mg hard capsules sunitinib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Pfizer Ltd

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5.OTHER

MON

TUE

WED

THU

FRI

SAT

SUN

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BLISTER OUTER CARTON - 25 MG CAPSULES

1.NAME OF THE MEDICINAL PRODUCT

Sutent 25 mg hard capsules sunitinib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

28x 1 hard capsules

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

EXP

9.SPECIAL STORAGE CONDITIONS

This medicinal product does not require any 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

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/347/005

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Sutent 25 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER – 25 MG CAPSULES

1. NAME OF THE MEDICINAL PRODUCT

Sutent 25 mg hard capsules sunitinib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Pfizer Ltd

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5.OTHER

MON

TUE

WED

THU

FRI

SAT

SUN

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BLISTER OUTER CARTON – 37.5 MG CAPSULES

1.NAME OF THE MEDICINAL PRODUCT

Sutent 37.5 mg hard capsules sunitinib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

28x 1 hard capsules

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

EXP

9.SPECIAL STORAGE CONDITIONS

This medicinal product does not require any 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

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/347/008

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Sutent 37.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER – 37.5 MG CAPSULES

1. NAME OF THE MEDICINAL PRODUCT

Sutent 37.5 mg hard capsules sunitinib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Pfizer Ltd

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5.OTHER

MON

TUE

WED

THU

FRI

SAT

SUN

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BLISTER OUTER CARTON - 50 MG CAPSULES

1.NAME OF THE MEDICINAL PRODUCT

Sutent 50 mg hard capsules sunitinib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

28x 1 hard capsules

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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

EXP

9.SPECIAL STORAGE CONDITIONS

This medicinal product does not require any 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

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/06/347/006

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Sutent 50 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER – 50 MG CAPSULES

1. NAME OF THE MEDICINAL PRODUCT

Sutent 50 mg hard capsules sunitinib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Pfizer Ltd

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch

5.OTHER

MON

TUE

WED

THU

FRI

SAT

SUN