Portrazza

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Withdrawn

This medicine's authorisation has been withdrawn

necitumumab
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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The European Public Assessment Report (EPAR) for Portrazza is updated to indicate that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: WITHDRAWAL
18/02/2021
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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).

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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

This page was last updated on

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