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
- 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
- 2. METHOD OF ADMINISTRATION
- 3. EXPIRY DATE
- 4. BATCH NUMBER
- 5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
- 6. OTHER
- 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
- 2. NAME OF THE MARKETING AUTHORISATION HOLDER
- 5. OTHER

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

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/1/06/347/001
13.BATCH NUMBER
Batch
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
Sutent 12.5 mg

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

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/1/06/347/002
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 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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
HDPE BOTTLE 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
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/1/06/347/007
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 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

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
BLISTER 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
- Duavive - Pfizer Limited
- Nimenrix - Pfizer Limited
- Rapamune - Pfizer Limited
- Trumenba - Pfizer Limited
- Toviaz - Pfizer Limited
- Onsenal - Pfizer Limited
Prescription drugs listed. Manufacturer: "Pfizer Limited"
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/1/06/347/004
13.BATCH NUMBER
Batch
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
Sutent 12.5 mg

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
- Rivastigmine teva
- Zyclara
- Imbruvica
- Biograstim
- Cyanokit
- Iblias
Prescription drugs listed:
SUN
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