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Yargesa (miglustat) – Labelling - A16AX06

Updated on site: 11-Oct-2017

Medication nameYargesa
ATC CodeA16AX06
Substancemiglustat
ManufacturerJensonR Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Yargesa 100 mg hard capsules

miglustat

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 100 mg miglustat.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

84 x 1 hard 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

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

JensonR+ Limited

Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1176/001

13.BATCH NUMBER<, DONATION AND PRODUCT CODES>

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Yargesa 100 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2Dbarcodecarryingtheuniqueidentifierincluded.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Yargesa 100 mg hard capsules

miglustat

2.NAME OF THE MARKETING AUTHORISATION HOLDER

JensonR+ Ltd.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

BN

5.OTHER

Comments

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