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Halaven (eribulin) – Labelling - L01XX41

Updated on site: 07-Oct-2017

Medication nameHalaven
ATC CodeL01XX41
Substanceeribulin
ManufacturerEisai Europe Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton 2ml vial

1.NAME OF THE MEDICINAL PRODUCT

HALAVEN 0.44 mg/ml solution for injection

Eribulin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin

3.LIST OF EXCIPIENTS

Ethanol anhydrous,Water for injections,Hydrochloric acid,Sodium hydroxide See leaflet for further information

4.PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 vial of 2 ml

6 vials of 2 ml

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous 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

CYTOTOXIC

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

Eisai Europe Ltd

European Knowledge Centre

Mosquito Way

Hatfield

Hertfordshire

AL10 9SN

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/678/001 1 vial

EU/1/11/678/002 6 vials

13.BATCH NUMBER

Lot:

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial 2 ml vial

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

HALAVEN 0.44 mg/ml injection

Eribulin

IV

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

Lot:

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Contains 0.88 mg eribulin in 2 ml

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton 3 ml vial

1. NAME OF THE MEDICINAL PRODUCT

HALAVEN 0.44 mg/ml solution for injection

Eribulin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each 3 ml vial contains eribulin mesilate equivalent to 1.32 mg eribulin

3. LIST OF EXCIPIENTS

Ethanol anhydrous,Water for injections, Hydrochloric acid, Sodium hydroxide See leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

Solution for injection

1 vial of 3 ml

6 vials of 3 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intravenous 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

CYTOTOXIC

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

Eisai Europe Ltd

European Knowledge Centre

Mosquito Way

Hatfield

Hertfordshire

AL10 9SN

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/678/003 1 vial

EU/1/11/678/004 6 vials

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial 3 ml vial

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

HALAVEN 0.44 mg/ml injection

Eribulin

IV

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Contains 1.32 mg eribulin in 3 ml

6. OTHER

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