- 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The European Public Assessment Report (EPAR) for Portrazza is updated to indicate that the marketing authorisation is no longer valid.
Product information
This medicine’s product information is available in all official EU languages.
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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).
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 agentsTherapeutic 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.