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Zavesca (miglustat) – Labelling - A16AX06

Updated on site: 11-Oct-2017

Medication nameZavesca
ATC CodeA16AX06
Substancemiglustat
ManufacturerActelion Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Zavesca 100 mg hard capsules

Miglustat

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 100 mg miglustat

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Hard capsule. 84 capsules

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral 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.

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

Actelion Registration Ltd

Chiswick Tower, 13th Floor

389 Chiswick High Road

London W4 4AL

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/02/238/001

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Zavesca

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Zavesca 100 mg hard capsules

Miglustat

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Actelion Registration Ltd

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch

5.OTHER

Comments

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