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Imatinib Teva (imatinib) – Labelling - L01XE01

Updated on site: 07-Oct-2017

Medication nameImatinib Teva
ATC CodeL01XE01
Substanceimatinib
ManufacturerTeva B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton

1.NAME OF THE MEDICINAL PRODUCT

Imatinib Teva 100 mg film-coated tablets imatinib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 100 mg of imatinib (as mesilate).

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet.

20x1 film-coated tablets

60 film-coated tablets

60x1 film-coated tablets

120 film-coated tablets

120x1 film-coated tablets

180x1 film-coated tablets

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

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/12/808/001

20 x 1 film-coated tablets

 

EU/1/12/808/002

60 film-coated tablets

 

 

 

EU/1/12/808/003

60 x 1 film-coated tablets

 

EU/1/12/808/004

120 film-coated tablets

 

 

EU/1/12/808/005

120 x 1 film-coated tablets

EU/1/12/808/006

180 x 1 film-coated tablets

EU/1/12/808/007

20 x 1 film-coated tablets

 

EU/1/12/808/008

60 film-coated tablets

 

 

EU/1/12/808/009

60 x 1 film-coated tablets

 

EU/1/12/808/010

120 film-coated tablets

 

 

EU/1/12/808/011

120 x 1 film-coated tablets

EU/1/12/808/012

180 x 1 film-coated tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Imatinib Teva 100 mg film-coated tablets

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 Teva 100 mg film-coated tablets imatinib

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

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

Imatinib Teva 400 mg film-coated tablets imatinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 400 mg of imatinib (as mesilate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet.

30 film-coated tablets

30x1 film-coated tablets

90 film-coated tablets

90x1 film-coated tablets

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

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/808/013

30 film-coated tablets

 

EU/1/12/808/014

30 x 1 film-coated tablets

EU/1/12/808/015

90 film-coated tablets

 

EU/1/12/808/016

90 x 1 film-coated tablets

EU/1/12/808/017

30 film-coated tablets

 

EU/1/12/808/018

30 x 1 film-coated tablets

EU/1/12/808/019

90 film-coated tablets

 

EU/1/12/808/020

90 x 1 film-coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Imatinib Teva 400 mg film-coated tablets

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 Teva 400 mg film-coated tablets imatinib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

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

Imatinib Teva 100 mg hard capsules imatinib

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

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

Teva 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

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Imatinib Teva 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 Teva 100 mg hard capsules imatinib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

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

Imatinib Teva 400 mg hard capsules imatinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 400 mg of imatinib (as mesilate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Capsule, hard

30 hard capsules

30x1 hard capsules

90 hard capsules

90x1 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

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

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/808/033

30 hard capsules

 

EU/1/12/808/034

30 x 1 hard capsules

EU/1/12/808/035

90 hard capsules

 

EU/1/12/808/036

90 x 1 hard capsules

EU/1/12/808/037

30 hard capsules

 

EU/1/12/808/038

30 x 1 hard capsules

EU/1/12/808/039

90 hard capsules

 

EU/1/12/808/040

90 x 1 hard capsules

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Imatinib Teva 400 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 Teva 400 mg hard capsules imatinib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Teva B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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