Cyramza

RSS

ramucirumab

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

Overview

This is a summary of the European public assessment report (EPAR) for Cyramza. 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 Cyramza.

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

This EPAR was last updated on 03/04/2018

Authorisation details

Product details
Name
Cyramza
Agency product number
EMEA/H/C/002829
Active substance
Ramucirumab
International non-proprietary name (INN) or common name
ramucirumab
Therapeutic area (MeSH)
Stomach Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC
Additional 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
Eli Lilly Nederland B.V.
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
18/12/2014
Contact address
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

12/02/2018 Cyramza - EMEA/H/C/002829 - IG/0898

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

Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy (see section 5.1).

Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate (see section 5.1).

Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5 fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.

Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.

Assessment history

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