Portrazza

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necitumumab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Medicine has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 27/07/2021

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
3
Date of issue of marketing authorisation valid throughout the European Union
15/02/2016
Contact address

Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

18/02/2021 Portrazza - EMEA/H/C/003886 - WITHDRAWAL

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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