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Fampyra (fampridine) – Labelling - N07XX07

Updated on site: 06-Oct-2017

Medication nameFampyra
ATC CodeN07XX07
Substancefampridine
ManufacturerBiogen Idec Ltd  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOTTLE CARTON

1.NAME OF THE MEDICINAL PRODUCT

Fampyra 10 mg prolonged-release tablets fampridine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg of fampridine.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

28 prolonged-release tablets (2 bottles of 14 tablets each) 56 prolonged-release tablets (4 bottles of 14 tablets each)

5.METHOD AND ROUTE(S) OF ADMINISTRATION

For 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

After first opening a bottle, use within 7 days.

9.SPECIAL STORAGE CONDITIONS

Store below 25°C. Store the tablets in the original bottle 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

Biogen Idec Limited

Innovation House

70 Norden Road

Maidenhead

Berkshire

SL6 4AY

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/699/001 28 tablets

EU/1/11/699/002 56 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Fampyra

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 SMALL IMMEDIATE PACKAGING UNITS

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Fampyra 10 mg prolonged-release tablets fampridine

Oral use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

After first opening a bottle, use within 7 days.

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

14 prolonged-release tablets

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BLISTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Fampyra 10 mg prolonged-release tablets fampridine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg of fampridine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

28 prolonged-release tablets (2 blisters of 14 tablets each) 56 prolonged-release tablets (4 blisters of 14 tablets each)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For 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

Store below 25°C. Store the tablets in the original packaging 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

Biogen Idec Limited

Innovation House

70 Norden Road

Maidenhead

Berkshire

SL6 4AY

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/699/003 28 tablets

EU/1/11/699/004 56 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Fampyra

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

Fampyra 10 mg prolonged-release tablets fampridine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Biogen Idec Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5.OTHER

leave 12 hours between each tablet

Mon.

Tue.

Wed.

Thu.

Fri.

Sat.

Sun.

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