Kisplyx

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lenvatinib

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Kisplyx. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Kisplyx.

For practical information about using Kisplyx, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 01/08/2019

Authorisation details

Product details
Name
Kisplyx
Agency product number
EMEA/H/C/004224
Active substance
lenvatinib mesilate
International non-proprietary name (INN) or common name
lenvatinib
Therapeutic area (MeSH)
Carcinoma, Renal Cell
Anatomical therapeutic chemical (ATC) code
L01XE29
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
  • Eisai GmbH
  • Eisai GmbH
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
25/08/2016

Product information

27/06/2019 Kisplyx - EMEA/H/C/004224 - WS/1607

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

In combination with everolimus for the treatment of unresectable advanced or metastatic renal cell carcinoma.

Assessment history

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