Portrazza
necitumumab
Table of contents
Overview
The marketing authorisation for Medicine has been withdrawn at the request of the marketing-authorisation holder.
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List item
Portrazza : EPAR - Summary for the public (PDF/661.27 KB)
First published: 04/03/2016
Last updated: 27/07/2021
EMA/14106/2016 -
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List item
Portrazza : EPAR - Risk-management-plan summary (PDF/755.01 KB)
First published: 04/03/2016
Last updated: 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 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 |
Product information
18/02/2021 Portrazza - EMEA/H/C/003886 - WITHDRAWAL
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.