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MedicineX 100 mg hard capsules (Labelling)
LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton
1. NAME OF THE MEDICINAL PRODUCT
Imatinib CompanyY 100 mg hard capsules
ProductX
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each hard capsule contains 100 mg of imatinib (as mesilate).
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
Capsule, hard
20x1 hard capsules
60 hard capsules
60x1 hard capsules
120 hard capsules
120x1 hard capsules
180x1 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
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
CompanyY B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/12/808/021 20 x 1 hard capsules
EU/1/12/808/022 60 hard capsules
EU/1/12/808/023 60 x 1 hard capsules
EU/1/12/808/024 120 hard capsules
EU/1/12/808/025 120 x 1 hard capsules
EU/1/12/808/026 180 x 1 hard capsules
EU/1/12/808/027 20 x 1 hard capsules
EU/1/12/808/028 60 hard capsules
EU/1/12/808/029 60 x 1 hard capsules
EU/1/12/808/030 120 hard capsules
EU/1/12/808/031 120 x 1 hard capsules
EU/1/12/808/032 180 x 1 hard capsules
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Imatinib CompanyY 100 mg hard capsules
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
1. NAME OF THE MEDICINAL PRODUCT
Imatinib CompanyY 100 mg hard capsules
imatinib
2. NAME OF THE MARKETING AUTHORISATION HOLDER
CompanyY B.V.
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot