Is Dacomitinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Dacomitinib, including VIZIMPRO (45 mg, Film-coated tablet, SAR 8836.20); VIZIMPRO (30 mg, Film-coated tablet, SAR 8836.20); VIZIMPRO (15 mg, Film-coated tablet, SAR 8836.20).

Is Dacomitinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Dacomitinib, including VIZIMPRO (Discontinued).

Is Dacomitinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Dacomitinib: Vizimpro.

Are there safety signals or safety updates for Dacomitinib?

US FDA: 1 entry (latest 2020-12-18).

Active substance

Dacomitinib

SFDA 3
US FDA 1
EMA 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
VIZIMPRO	45 mg	Film-coated tablet · Oral use	30 Bottle	SAR 8836.20	NCE · Prescription	PFIZER INC	Valid
VIZIMPRO	30 mg	Film-coated tablet · Oral use	30 Bottle	SAR 8836.20	NCE · Prescription	PFIZER INC	Valid
VIZIMPRO	15 mg	Film-coated tablet · Oral use	30 Bottle	SAR 8836.20	NCE · Prescription	PFIZER INC	Valid

Indications — CHI Daman Drug Formulary

NON-SMALL-CELL LUNG CARCINOMA (NSCLC)

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

Product	Strength	Form · route	Applicant	Status	First approved
VIZIMPRO	15MG; 30MG; 45MG	tablet · oral	PFIZER	Discontinued	27 Sep 2018

EMA European Union — centrally authorised medicines

Vizimpro Pfizer Europe MA EEIG · Authorised · authorised 2 Apr 2019 · ATC L01EB07

Therapeutic indication (EMA)

Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.

Safety signals and safety-related labeling changes

US FDA 18 Dec 2020 VIZIMPRO — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for dacomitinib →

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.