Portrazza

RSS

necitumumab

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

Overview

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

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

This EPAR was last updated on 05/12/2016

Authorisation details

Product details
Name
Portrazza
Agency product number
EMEA/H/C/003886
Active substance
necitumumab
International non-proprietary name (INN) or common name
necitumumab
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01
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
Eli Lilly Nederland B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
15/02/2016
Contact address

Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

10/11/2016 Portrazza - EMEA/H/C/003886 - II/0002

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

Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.

Assessment history

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