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Vaniqa (eflornithine) – Labelling - D11AX

Updated on site: 10-Oct-2017

Medication nameVaniqa
ATC CodeD11AX
Substanceeflornithine
ManufacturerAlmirall, S.A.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON TEXT

1.NAME OF THE MEDICINAL PRODUCT

Vaniqa 11.5% cream

Eflornithine

2.STATEMENT OF ACTIVE SUBSTANCE

Each gram of cream contains 115 mg eflornithine (as hydrochloride monohydrate).

3.LIST OF EXCIPIENTS

Also contains: cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water; stearyl alcohol and sodium hydroxide (to adjust pH).

4.PHARMACEUTICAL FORM AND CONTENTS

Cream 15 g 30 g 60 g

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Cutaneous 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

Discard the tube 6 months after opening.

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

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

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain.

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/173/001

EU/1/01/173/002

EU/1/01/173/003

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Vaniqa

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

TUBES

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

Vaniqa 11.5% cream

Eflornithine

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

Cutaneous use

3.EXPIRY DATE

EXP

Discard the tube 6 months after opening.

4.BATCH NUMBER

Batch

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

15 g

30 g

60 g

6.OTHER

Almirall, S.A.

Keep out of the sight and reach of children.

Do not store above 25°C.

Comments

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