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Zonegran (zonisamide) – Labelling - N03AX15

Updated on site: 11-Oct-2017

Medication nameZonegran
ATC CodeN03AX15
Substancezonisamide
ManufacturerEisai Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Zonegran 25 mg hard capsules zonisamide

2.STATEMENT OF ACTIVE SUBSTANCE

Each hard capsule contains 25 mg zonisamide.

3.LIST OF EXCIPIENTS

Hydrogenated vegetable oil (from soyabean)

4.PHARMACEUTICAL FORM AND CONTENTS

14 hard capsules

28 hard capsules

56 hard capsules

84 hard capsules

5.METHOD AND ROUTE 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 WARNINGS, IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 30ºC.

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

10.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Eisai Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.

11.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/307/001 14 capsules

EU/1/04/307/005 28 capsules

EU/1/04/307/002 56 capsules

EU/1/04/307/013 84 capsules

12.BATCH NUMBER

Lot

13.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

14.INSTRUCTIONS ON USE

15.INFORMATION IN BRAILLE

Zonegran 25 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

Blister Pack

1. NAME OF THE MEDICINAL PRODUCT

Zonegran 25 mg hard capsules zonisamide

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Eisai 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

Zonegran 50 mg hard capsules zonisamide

2. STATEMENT OF ACTIVE SUBSTANCE

Each hard capsule contains 50 mg zonisamide.

3. LIST OF EXCIPIENTS

Hydrogenated vegetable oil (from soyabean)

4. PHARMACEUTICAL FORM AND CONTENTS

14 hard capsules

28 hard capsules

56 hard capsules

84 hard capsules

5. METHOD AND ROUTE 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 WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30ºC.

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 Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/307/010 14 capsules

EU/1/04/307/009 28 capsules

EU/1/04/307/003 56 capsules

EU/1/04/307/012 84 capsules

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Zonegran 50 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

Blister Pack

1. NAME OF THE MEDICINAL PRODUCT

Zonegran 50 mg hard capsules zonisamide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Eisai 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

Zonegran 100 mg hard capsules zonisamide

2. STATEMENT OF ACTIVE SUBSTANCE

Each hard capsule contains 100 mg zonisamide.

3. LIST OF EXCIPIENTS

Contains also hydrogenated vegetable oil (from soyabean), sunset yellow FCF (E110) and allura red AC (E129). See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

28 hard capsules

56 hard capsules

84 hard capsules

98 hard capsules

196 hard capsules

5. METHOD AND ROUTE 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 WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30ºC.

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 Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/04/307/006 28 capsules

EU/1/04/307/004 56 capsules

EU/1/04/307/011 84 capsules

EU/1/04/307/007 98 capsules

EU/1/04/307/008 196 capsules

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zonegran 100 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

Blister Pack

1. NAME OF THE MEDICINAL PRODUCT

Zonegran 100 mg hard capsules zonisamide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Eisai 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

Zonegran 25 mg orodispersible tablets zonisamide

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 25 mg of zonisamide.

3. LIST OF EXCIPIENTS

Also contains aspartame (E951). See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 orodispersible tablets

28 orodispersible tablets

5. METHOD AND ROUTE 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 WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light and 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 Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

EU/1/04/307/014

 

 

14 orodispersible tablets

EU/1/04/307/015

28 orodispersible tablets

 

 

 

13.

BATCH NUMBER

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zonegran 25 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

Blister Pack

1. NAME OF THE MEDICINAL PRODUCT

Zonegran 25 mg orodispersible tablets zonisamide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Eisai 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

Zonegran 50 mg orodispersible tablets zonisamide

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 50 mg of zonisamide.

3. LIST OF EXCIPIENTS

Also contains aspartame (E951). See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 orodispersible tablets

28 orodispersible tablets

5. METHOD AND ROUTE 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 WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light and 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 Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

EU/1/04/307/016

 

 

14 orodispersible tablets

EU/1/04/307/017

28 orodispersible tablets

 

 

 

13.

BATCH NUMBER

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zonegran 50 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

Blister Pack

1. NAME OF THE MEDICINAL PRODUCT

Zonegran 50 mg orodispersible tablets zonisamide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Eisai 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

Zonegran 100 mg orodispersible tablets zonisamide

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 100 mg of zonisamide.

3. LIST OF EXCIPIENTS

Also contains aspartame (E951). See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

56 orodispersible tablets

98 orodispersible tablets

5. METHOD AND ROUTE 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 WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light and 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 Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

EU/1/04/307/018

 

 

56 orodispersible tablets

 

EU/1/04/307/019

98 orodispersible tablets

 

 

 

 

 

13.

BATCH NUMBER

 

 

 

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zonegran 100 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

Blister Pack

1. NAME OF THE MEDICINAL PRODUCT

Zonegran 100 mg orodispersible tablets zonisamide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Eisai 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

Zonegran 300 mg orodispersible tablets zonisamide

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 300 mg of zonisamide.

3. LIST OF EXCIPIENTS

Also contains aspartame (E951). See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

28 orodispersible tablets

98 orodispersible tablets

5. METHOD AND ROUTE 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 WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light and 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 Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

EU/1/04/307/020

 

 

28 orodispersible tablets

 

EU/1/04/307/021

98 orodispersible tablets

 

 

 

13.

BATCH NUMBER

 

Lot

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zonegran 300 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

Blister Pack

1. NAME OF THE MEDICINAL PRODUCT

Zonegran 300 mg orodispersible tablets zonisamide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Eisai Ltd.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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