Sancuso (granisetron) – Labelling - A04AA02

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

SANCUSO 3.1 mg/24 hours transdermal patch Granisetron

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each 52 cm2 transdermal patch contains 34.3 mg of granisetron, releasing 3.1 mg of granisetron per

24hours.

3.LIST OF EXCIPIENTS

Other ingredients: acrylate-vinylacetate copolymer, polyester, siliconised polyester.

4.PHARMACEUTICAL FORM AND CONTENTS

1 transdermal patch

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Transdermal 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

Store in the original package in order to protect from light.

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

Kyowa Kirin Ltd, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom.

12.MARKETING AUTHORISATION NUMBERS

EU/1/12/766/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Sancuso

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET

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

SANCUSO 3.1 mg/24 h transdermal patch Granisetron

Transdermal use

2.METHOD OF ADMINISTRATION

Read the package leaflet before use.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 transdermal patch

6.OTHER

Store in the original package in order to protect from light.

Keep out of the sight and reach of children.

Kyowa Kirin Ltd