Is Necitumumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Necitumumab, including PORTRAZZA (Prescription).

Is Necitumumab authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Necitumumab.

Active substance

Necitumumab

US FDA 1
EMA 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PORTRAZZA	800MG/50ML	injectable · intra-articular, intramuscular, intravitreal	ELI LILLY CO	Prescription	24 Nov 2015

EMA European Union — centrally authorised medicines

Portrazza Eli Lilly Nederland B.V. · Withdrawn · authorised 15 Feb 2016 · ATC L01

Therapeutic indication (EMA)

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.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.