Overview
The marketing authorisation for Medicine has been withdrawn at the request of the marketing-authorisation holder.
Portrazza : EPAR - Summary for the public
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.
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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).
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 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.
Assessment history
Portrazza : EPAR - Procedural steps taken and scientific information after authorisation