Portrazza

Withdrawn

This medicine's authorisation has been withdrawn

necitumumab

Overview

The marketing authorisation for Medicine has been withdrawn at the request of the marketing-authorisation holder.

Portrazza : EPAR - Summary for the public

Reference Number: EMA/14106/2016

Portrazza : EPAR - Risk-management-plan summary

Product information

Portrazza : EPAR - Product Information

Latest procedure affecting product information: WITHDRAWAL

18/02/2021

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).

Portrazza : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Portrazza
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/003886
• Marketing authorisation holder:
  Eli Lilly Nederland B.V.

  Papendorpseweg 83; 3528 BJ Utrecht; Netherlands

• Marketing authorisation issued:
  15/02/2016
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Portrazza : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Portrazza : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/15391/2016

Summary of opinion for Portrazza

AdoptedReference Number: EMA/CHMP/756429/2015