Portrazza

Withdrawn

This medicine's authorisation has been withdrawn

necitumumab

Overview

The marketing authorisation for Portrazza (necitumumab) expired on 18 February 2021 following the decision of the marketing authorisation holder, Eli Lilly Nederland B.V., not to apply for a renewal of the marketing authorisation. 

Eli Lilly Nederland B.V. confirmed that it did not apply for renewal of the authorisation due to the lack of demand for this product. Portrazza was granted marketing authorisation in the European Union (EU) on 15 February 2016 for the treatment of squamous non-small cell lung cancer. 

The marketing authorisation was valid for a 5- year period. The marketing authorisation holder has committed to ensure that patients who benefit from Portrazza for the treatment of locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer can continue to receive treatment as appropriate. 

The European Public Assessment Report (EPAR) for Portrazza is updated to indicate that the marketing authorisation is no longer valid.

Portrazza : EPAR - Summary for the public

Reference Number: EMA/14106/2016

Portrazza : EPAR - Risk-management-plan summary

Product information

Portrazza : EPAR - Product Information

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.

  Orteliuslaan 1000 ; 3528 BD 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

Adopted Reference Number: EMA/CHMP/15391/2016

Summary of opinion for Portrazza

Adopted Reference Number: EMA/CHMP/756429/2015