PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
1.NAME OF THE MEDICINAL PRODUCT
Kisplyx 4 mg hard capsules lenvatinib
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each hard capsule contains 4 mg lenvatinib (as mesilate).
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
30 hard capsules
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 EXP
9.SPECIAL STORAGE CONDITIONS Do
not store above 25°C.
Store in the original blister in order to protect from moisture.
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
Eisai Europe Ltd.
Mosquito Way Hatfield Herts AL10 9SN United Kingdom
12.MARKETING AUTHORISATION NUMBER(S) EU/1/16/1128/001
13.BATCH NUMBER Lot 

14.GENERAL CLASSIFICATION FOR SUPPLY 

15.INSTRUCTIONS ON USE 

16.INFORMATION IN BRAILLE
Kisplyx 4 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 BLISTERS 

1. NAME OF THE MEDICINAL PRODUCT
Kisplyx 4 mg hard capsules lenvatinib 

2.NAME OF THE MARKETING AUTHORISATION HOLDER
Eisai Europe Ltd. 

3.EXPIRY DATE EXP 

4.BATCH NUMBER
Lot 

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
1. NAME OF THE MEDICINAL PRODUCT
Kisplyx 10 mg hard capsules lenvatinib
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each hard capsule contains 10 mg lenvatinib (as mesyilate).
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
30 hard capsules
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 EXP
9. SPECIAL STORAGE CONDITIONS Do
not store above 25°C.
Store in the original blister in order to protect from moisture.
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
Eisai Europe Ltd. Mosquito Way Hatfield Herts AL10 9SN United Kingdom
12. MARKETING AUTHORISATION NUMBER(S) EU/1/16/1128/002 

13. BATCH NUMBER Lot 

14. GENERAL CLASSIFICATION FOR SUPPLY 

15. INSTRUCTIONS ON USE 

16. INFORMATION IN BRAILLE
Kisplyx 10 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 BLISTERS 

1. NAME OF THE MEDICINAL PRODUCT
Kisplyx 10 mg hard capsules lenvatinib 

2. NAME OF THE MARKETING AUTHORISATION HOLDER Eisai Europe Ltd. 

3. EXPIRY DATE EXP 

4. BATCH NUMBER 

Lot