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Xagrid (anagrelide) – Labelling - L01XX35

Updated on site: 10-Oct-2017

Medication nameXagrid
ATC CodeL01XX35
Substanceanagrelide
ManufacturerShire Pharmaceutical Contracts Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER CARTON AND BOTTLE LABEL

1.NAME OF THE MEDICINAL PRODUCT

Xagrid 0.5 mg hard capsules anagrelide

2.STATEMENT OF ACTIVE SUBSTANCE(S)

One hard capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride).

3.LIST OF EXCIPIENTS

Also contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

100 hard capsules

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

This medicinal product does not require any 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

Shire Pharmaceutical Contracts Ltd

Basingstoke

RG24 8EP

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/295/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Xagrid (on the outer carton only)

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

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