Is Erlotinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 14 valid registrations of Erlotinib, including CALIVERA (25 mg, Film-coated tablet, SAR 823.30); CALIVERA (100 mg, Film-coated tablet, SAR 3293.15); CALIVERA (150 mg, Film-coated tablet, SAR 4400.65); Erlotinib EPC (150 mg, Film-coated tablet, SAR 4419.10); Erlotinib EPC (100 mg, Film-coated tablet, SAR 3358.05).

Is Erlotinib approved by the US FDA?

Drugs@FDA lists 14 application product lines for Erlotinib, including ERLOTINIB HYDROCHLORIDE (Prescription); ERLOTINIB HYDROCHLORIDE (Prescription); ERLOTINIB HYDROCHLORIDE (Prescription); ERLOTINIB HYDROCHLORIDE (Prescription); ERLOTINIB HYDROCHLORIDE (Prescription).

Is Erlotinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Erlotinib: Tarceva.

Is Erlotinib on the WHO Model List of Essential Medicines?

Yes — 8.2.2. Targeted therapies (complementary list): Other specified malignant neoplasms of bronchus or lung.

Are there safety signals or safety updates for Erlotinib?

EMA PRAC: 3 entries; US FDA: 1 entry; MHRA: 1 entry (latest 2016-10-18).

Active substance

Erlotinib

SFDA 17
US FDA 14
EMA 2
Health Canada 7
WHO EML 1
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
CALIVERA	25 mg	Film-coated tablet · Oral use	30 Blister	SAR 823.30	Generic · Prescription	SPIMACO	Valid
CALIVERA	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 3293.15	Generic · Prescription	SPIMACO	Valid
CALIVERA	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 4400.65	Generic · Prescription	SPIMACO	Valid
Erlotinib EPC	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 4419.10	Generic · Prescription	Eastern Pharma Co (EPC)	Valid
Erlotinib EPC	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 3358.05	Generic · Prescription	Eastern Pharma Co (EPC)	Valid
Erlotinib SPC	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 3358.05	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Erlotinib SPC	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 4419.10	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Erloz	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 4419.10	Generic · Prescription	Saudi Amarox	Valid
Erloz	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 3358.05	Generic · Prescription	Saudi Amarox	Valid
PULECTUS 100 mg Film Coated Tablet	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 3731.15	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
PULECTUS 150 mg Film Coated Tablet	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 4419.10	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
TARCEVA 150 mg film-coated tablet	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 4910.10	NCE · Prescription	ROCHE	Valid
Tyrox	25 mg	Film-coated tablet · Oral use	30 Blister	SAR 930.30	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Tyrox	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 3721.15	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
TARCEVA 100 mg film-coated tablet	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 4592.15	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
TARCEVA 25 mg film-coated tablet	25 mg	Film-coated tablet · Oral use	30 Blister	SAR 1706.30	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
Tyrox	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 4986.85	Generic · Prescription	MS Pharma Saudi (MSPS)	Suspended · Not Marketed

Indications — CHI Daman Drug Formulary

MALIGNANT NEOPLASM OF THE PANCREAS; RENAL CELL CARCINOMA (RCC)-CC-RCC & NON-CC RCC; VAGINAL AND VULVAR CANCERS

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

Product	Strength	Form · route	Applicant	Status	First approved
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 100MG BASE; EQ 150MG BASE	tablet · oral	RISING	Prescription	11 Jun 2014
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 100MG BASE; EQ 150MG BASE	tablet · oral	TEVA PHARMS USA INC	Prescription	28 Aug 2015
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 100MG BASE; EQ 150MG BASE	tablet · oral	ADAPTIS	Prescription	5 Nov 2019
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 100MG BASE; EQ 150MG BASE	tablet · oral	ZYDUS PHARMS	Prescription	16 Apr 2020
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 100MG BASE; EQ 150MG BASE	tablet · oral	MSN	Prescription	10 May 2021
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 100MG BASE; EQ 150MG BASE	tablet · oral	ALEMBIC	Prescription	8 Jul 2021
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 100MG BASE; EQ 150MG BASE	tablet · oral	HETERO LABS LTD V	Prescription	24 May 2024
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 150MG BASE	tablet · oral	CHARTWELL RX	Prescription	13 Sep 2024
TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	OSI PHARMS	Discontinued	18 Nov 2004
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 100MG BASE; EQ 150MG BASE	tablet · oral	APOTEX	Discontinued	5 Nov 2019
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 100MG BASE; EQ 150MG BASE	tablet · oral	NATCO PHARMA LTD	Discontinued	5 Nov 2019
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 100MG BASE; EQ 150MG BASE	tablet · oral	SUN PHARM	Discontinued	5 Nov 2019
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 100MG BASE; EQ 150MG BASE	tablet · oral	ACCORD HLTHCARE	Discontinued	2 Jul 2020
ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE; EQ 100MG BASE; EQ 150MG BASE	tablet · oral	EUGIA PHARMA	Discontinued	22 Jun 2022

EMA European Union — centrally authorised medicines

Tarceva Cheplapharm Registration GmbH · Authorised · authorised 19 Sep 2005 · ATC L01EB02

Therapeutic indication (EMA)

Non-small cell lung cancer (NSCLC) Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours. Pancreatic cancer Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer. When prescribing Tarceva, factors associated with prolonged survival should be taken into account.

Erlotinib Accord Accord Healthcare S.L.U. · Application withdrawn · ATC L01XE03

Therapeutic indication (EMA)

Treatment of lung and pancreatic cancers

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-ERLOTINIB	02461862	25 MG	TABLET · ORAL	APOTEX INC
APO-ERLOTINIB	02461870	100 MG	TABLET · ORAL	APOTEX INC
APO-ERLOTINIB	02461889	150 MG	TABLET · ORAL	APOTEX INC
PMS-ERLOTINIB	02454394	150 MG	TABLET · ORAL	PHARMASCIENCE INC
TEVA-ERLOTINIB	02377691	25 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-ERLOTINIB	02377705	100 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-ERLOTINIB	02377713	150 MG	TABLET · ORAL	TEVA CANADA LIMITED

WHO WHO Model List of Essential Medicines (2025)

8.2.2. Targeted therapies · complementary
Other specified malignant neoplasms of bronchus or lung
Oral > Solid: 100 mg; 150 mg

Safety signals and safety-related labeling changes

US FDA 18 Oct 2016 TARCEVA — 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
MHRA 11 Dec 2014 Erlotinib: new safety information
New safety information for intensive monitoring of Erlotinib.
EMA PRAC 3 Oct 2012 PRAC signal: Palmar-plantar erythrodysaesthesia syndrome (PPES)
Action for MAH: update of the product information: Yes
EMA PRAC 3 Oct 2012 PRAC signal: Pancreatitis
Action for MAH: update of the product information: No
EMA PRAC 3 Oct 2012 PRAC signal: Vasculitis
Action for MAH: update of the product information: No

All safety entries for erlotinib →

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.