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Targretin (bexarotene) – Labelling - L01XX25

Updated on site: 10-Oct-2017

Medication nameTargretin
ATC CodeL01XX25
Substancebexarotene
ManufacturerEisai Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER CARTON TEXT AND BOTTLE LABEL TEXT

1.NAME OF THE MEDICINAL PRODUCT

Targretin 75 mg soft capsules

Bexarotene

2.STATEMENT OF ACTIVE SUBSTANCE

One capsule contains 75 mg of bexarotene.

3.LIST OF EXCIPIENTS

Contains sorbitol. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

100 soft capsules

5.METHOD AND ROUTE OF ADMINISTRATION

Oral use.

To be swallowed whole.

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

Do not store above 30 C.

Keep the bottle tightly closed.

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 Ltd.

Mosquito Way

Hatfield

Hertfordshire

AL10 9SN

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/178/001

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Targretin 75 mg

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