SANCUSO Transdermal patch Ref.[8214] Active ingredients: Granisetron

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands, Tel: +31 (0) 237200822

Product name and form

SANCUSO 3.1 mg/24 hours transdermal patch.

Pharmaceutical Form

Transdermal patch.

Thin, translucent, matrix-type, rectangular-shaped transdermal patch with rounded corners.

Qualitative and quantitative composition

Each 52 cm² transdermal patch contains 34.3 mg of granisetron releasing 3.1 mg of granisetron per 24 hours.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Granisetron

Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5HT3 receptors). Pharmacological studies have demonstrated that granisetron is effective against nausea and vomiting as a result of cytostatic therapy.

List of Excipients

Backing layer: Polyester

Matrix layer: Acrylate-vinylacetate copolymer

Release liner: Siliconised polyester

Pack sizes and marketing

Each transdermal patch is packaged in a heat-sealed sachet composed of polyester-coated paper/aluminium/LLDPE.

Each carton contains 1 transdermal patch.

Marketing authorization holder

Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands, Tel: +31 (0) 237200822

Marketing authorization dates and numbers

EU/1/12/766/001

Date of first authorisation: 20 April 2012
Date of latest renewal: 9 January 2017

Drugs

Drug Countries
SANCUSO Austria, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, United Kingdom, United States

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