Is Osimertinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Osimertinib, including TAGRISSO 40 mg Film-Coated Tablet (40 mg, Film-coated tablet, SAR 28409.90); TAGRISSO 80 mg Film-Coated Tablet (80 mg, Film-coated tablet, SAR 28409.90).

Is Osimertinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Osimertinib, including TAGRISSO (Prescription).

Is Osimertinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Osimertinib: Tagrisso.

Are there safety signals or safety updates for Osimertinib?

EMA PRAC: 6 entries; US FDA: 1 entry (latest 2026-09-14).

Active substance

Osimertinib

SFDA 2
US FDA 1
EMA 1
Health Canada 2
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TAGRISSO 40 mg Film-Coated Tablet	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 28409.90	NCE · Prescription	AstraZeneca	Valid
TAGRISSO 80 mg Film-Coated Tablet	80 mg	Film-coated tablet · Oral use	30 Blister	SAR 28409.90	NCE · Prescription	AstraZeneca	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
TAGRISSO	EQ 40MG BASE; EQ 80MG BASE	tablet · oral	ASTRAZENECA	Prescription	13 Nov 2015

EMA European Union — centrally authorised medicines

Tagrisso AstraZeneca AB · Authorised · authorised 1 Feb 2016 · ATC L01XE

Therapeutic indication (EMA)

Tagrisso as monotherapy is indicated for: the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1). the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum‑based chemoradiation therapy. the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. Tagrisso is indicated in combination with: pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TAGRISSO	02456214	40 MG	TABLET · ORAL	ASTRAZENECA CANADA INC
TAGRISSO	02456222	80 MG	TABLET · ORAL	ASTRAZENECA CANADA INC

Safety signals and safety-related labeling changes

US FDA 14 Sep 2026 TAGRISSO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Jun 2026 PRAC signal: Pulmonary alveolar haemorrhage
Action for MAH: update of the product information: No
EMA PRAC 4 Sep 2025 PRAC signal: Hepatitis B reactivation
Action for MAH: update of the product information: Yes
EMA PRAC 8 May 2025 PRAC signal: Hepatitis B reactivation
Action for MAH: update of the product information: No
EMA PRAC 26 Oct 2023 PRAC signal: Progressive multifocal leukoencephalopathy
Action for MAH: update of the product information: No
EMA PRAC 31 Aug 2023 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: No
EMA PRAC 13 Jan 2022 PRAC signal: Aplastic anaemia
Action for MAH: update of the product information: No

All safety entries for osimertinib →

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.