Is Afatinib 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 Afatinib, including GIOTRIF 30 mg film-coated tablet (30 mg, Film-coated tablet, SAR 7381.00); GIOTRIF 40 mg film-coated tablet (40 mg, Film-coated tablet, SAR 7381.00).

Is Afatinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Afatinib: Giotrif.

Is Afatinib on the WHO Model List of Essential Medicines?

Yes — 8.2.2. Targeted therapies (complementary list): Therapeutic equivalent to erlotinib for Other specified malignant neoplasms of bronchus or lung.

Are there safety signals or safety updates for Afatinib?

EMA PRAC: 2 entries (latest 2025-01-16).

Active substance

Afatinib

SFDA 4
EMA 1
Health Canada 9
WHO EML 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
GIOTRIF 30 mg film-coated tablet	30 mg	Film-coated tablet · Oral use	28 Blister	SAR 7381.00	NCE · Prescription	BOEHRINGER INGELHEIM	Valid
GIOTRIF 40 mg film-coated tablet	40 mg	Film-coated tablet · Oral use	28 Blister	SAR 7381.00	NCE · Prescription	BOEHRINGER INGELHEIM	Valid
GIOTRIF 20 mg film-coated tablet	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 8983.05	NCE · Prescription	BOEHRINGER INGELHEIM	Withdrawn by MAH · Not Marketed
GIOTRIF 50 mg film-coated tablet	50 mg	Film-coated tablet · Oral use	28 Blister	SAR 8983.05	NCE · Prescription	BOEHRINGER INGELHEIM	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

NON-SMALL-CELL LUNG CARCINOMA (NSCLC)

EMA European Union — centrally authorised medicines

Giotrif Boehringer Ingelheim International GmbH · Authorised · authorised 25 Sep 2013 · ATC L01XE13

Therapeutic indication (EMA)

Giotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
GIOTRIF	02415666	20 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
GIOTRIF	02415674	30 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
GIOTRIF	02415682	40 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
MAR-AFATINIB	02517019	20 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MAR-AFATINIB	02517027	30 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MAR-AFATINIB	02517035	40 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
SANDOZ AFATINIB	02512777	20 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ AFATINIB	02512785	30 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ AFATINIB	02512793	40 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED

WHO WHO Model List of Essential Medicines (2025)

8.2.2. Targeted therapies · complementary
Therapeutic equivalent to erlotinib for Other specified malignant neoplasms of bronchus or lung

Safety signals and safety-related labeling changes

EMA PRAC 16 Jan 2025 PRAC signal: Growth of eyelashes
Action for MAH: update of the product information: Yes
EMA PRAC 30 Nov 2023 PRAC signal: Growth of eyelashes
Action for MAH: update of the product information: No

All safety entries for afatinib →

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.