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Xadago (safinamide methanesulfonate) – Labelling - N04B

Updated on site: 10-Oct-2017

Medication nameXadago
ATC CodeN04B
Substancesafinamide methanesulfonate
ManufacturerZambon SpA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON –film-coated tablets

1.NAME OF THE MEDICINAL PRODUCT

Xadago 50 mg film-coated tablets safinamide

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains safinamide methansulfonate equivalent to 50 mg safinamide.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

90 film-coated tablets

100 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

Zambon S.p.A.

Via Lillo del Duca 10 20091 Bresso (MI) - Italy

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/14/984/001

EU/1/14/984/002

EU/1/14/984/003

EU/1/14/984/004

EU/1/14/984/005

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

xadago 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

1. NAME OF THE MEDICINAL PRODUCT

Xadago 50 mg tablets safinamide

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Zambon S.p.A.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON – film-coated tablets

1. NAME OF THE MEDICINAL PRODUCT

Xadago 100 mg film-coated tablets safinamide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains safinamide methansulfonate equivalent to 100 mg safinamide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

90 film-coated tablets

100 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

Zambon S.p.A.

Via Lillo del Duca 10 20091 Bresso (MI) - Italy

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/984/006

EU/1/14/984/007

EU/1/14/984/008

EU/1/14/984/009

EU/1/14/984/010

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

xadago 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

1. NAME OF THE MEDICINAL PRODUCT

Xadago 100 mg tablets safinamide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Zambon S.p.A.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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