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Yervoy (ipilimumab) – Labelling - L01XC11

Updated on site: 11-Oct-2017

Medication nameYervoy
ATC CodeL01XC11
Substanceipilimumab
ManufacturerBristol-Myers Squibb Pharma EEIG

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

YERVOY 5 mg/ml concentrate for solution for infusion

Ipilimumab

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of concentrate contains 5 mg ipilimumab.

Each vial contains 50 mg ipilimumab.

Each vial contains 200 mg ipilimumab.

3.LIST OF EXCIPIENTS

Excipients: Tris hydrochloride, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Concentrate for solution for infusion

50 mg/10 ml

200 mg/40 ml

1 vial

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

For single use only.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package in order to protect from light.

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park - Sanderson Road

Uxbridge UB8 1DH - United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/698/001

EU/1/11/698/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT

YERVOY 5 mg/ml sterile concentrate

Ipilimumab

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of concentrate contains 5 mg ipilimumab.

Each vial contains 50 mg ipilimumab.

Each vial contains 200 mg ipilimumab.

3. LIST OF EXCIPIENTS

Excipients: Tris hydrochloride, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Sterile concentrate

50 mg/10 ml

200 mg/40 ml

5. METHOD AND ROUTE(S) OF ADMINISTRATION

IV 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

For single use only.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Store in the original package in order to protect from light.

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park - Sanderson Road

Uxbridge UB8 1DH - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/11/698/001

EU/1/11/698/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

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