Is Panitumumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Panitumumab, including VECTIBIX 20MG/ML CONC. SOLUTION FOR INFUSION (20 mg/ml, Concentrate for solution for infusion, SAR 2323.30).

Is Panitumumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Panitumumab, including VECTIBIX (Prescription).

Is Panitumumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Panitumumab: Vectibix.

Are there safety signals or safety updates for Panitumumab?

EMA PRAC: 1 entry; US FDA: 1 entry; MHRA: 3 entries (latest 2025-01-16).

Active substance

Panitumumab

SFDA 1
US FDA 1
EMA 1
Health Canada 2
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
VECTIBIX 20MG/ML CONC. SOLUTION FOR INFUSION	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 2323.30	NCE · Prescription	AMGEN EUROPE B.V.	Valid

Indications — CHI Daman Drug Formulary

COLORECTAL CANCER-ADVANCED/ METASTATIC

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

Product	Strength	Form · route	Applicant	Status	First approved
VECTIBIX	5ML/100MG; 10ML/200MG; 20ML/400MG	injectable · iv (infusion)	AMGEN	Prescription	27 Sep 2006

EMA European Union — centrally authorised medicines

Vectibix Amgen Europe B.V. · Authorised · authorised 3 Dec 2007 · ATC L01XC08

Therapeutic indication (EMA)

Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): in first-line in combination with Folfox or Folfiri. in second-line in combination with Folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VECTIBIX	02308487	100 MG / 5 ML	SOLUTION · INTRAVENOUS	AMGEN CANADA INC
VECTIBIX	02308509	400 MG / 20 ML	SOLUTION · INTRAVENOUS	AMGEN CANADA INC

Safety signals and safety-related labeling changes

US FDA 16 Jan 2025 VECTIBIX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 11 Dec 2014 Panitumumab: treatment of metastatic colorectal cancer
Importance of establishing wildtype RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer.
MHRA 11 Dec 2014 Panitumumab (Vectibix): risk of necrotising fasciitis
Five cases of necrotising fasciitis have been reported in patients treated with panitumumab in combination with chemotherapy.
MHRA 11 Dec 2014 Panitumumab (Vectibix): serious hypersensitivity reactions
New reports of serious hypersensitivity reactions (including anaphylaxis) in patients receiving panitumumab, some of which were fatal.
EMA PRAC 6 Feb 2014 PRAC signal: Increased fatal adverse events in patients with advanced solid tumours – publication from clinical trials
Action for MAH: update of the product information: No

All safety entries for panitumumab →

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.