Is Temozolomide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 10 valid registrations of Temozolomide, including LAGONA 100 mg Hard capsule (100 mg, Capsule, hard, SAR 1017.55); LAGONA 20 mg Hard capsule (20 mg, Capsule, hard, SAR 214.55); LAGONA 5 mg Hard capsule (5 mg, Capsule, hard, SAR 53.65); TEGOZOL 100 mg Capsule (100 mg, Capsule, SAR 1096.70); TEGOZOL 20 mg Capsule (20 mg, Capsule, SAR 231.25).

Is Temozolomide approved by the US FDA?

Drugs@FDA lists 19 application product lines for Temozolomide, including TEMODAR (Prescription); TEMOZOLOMIDE (Prescription); TEMOZOLOMIDE (Prescription); TEMOZOLOMIDE (Prescription); TEMOZOLOMIDE (Prescription).

Is Temozolomide authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Temozolomide: Temodal, Temomedac, Temozolomide Teva, Temozolomide Accord, Temozolomide Sun.

Are there safety signals or safety updates for Temozolomide?

EMA PRAC: 10 entries; US FDA: 2 entries; MHRA: 1 entry (latest 2023-09-14).

Active substance

Temozolomide

SFDA 22
US FDA 19
EMA 8
Health Canada 25
US price lines 3
Safety 13

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LAGONA 100 mg Hard capsule	100 mg	Capsule, hard · Oral use	5 Sachet	SAR 1017.55	Generic · Prescription	SPIMACO ADDWAEIH	Valid
LAGONA 100 mg Hard capsule	100 mg	Capsule, hard · Oral use	20 Sachet	SAR 4070.15	Generic · Prescription	SPIMACO ADDWAEIH	Valid
LAGONA 20 mg Hard capsule	20 mg	Capsule, hard · Oral use	5 Sachet	SAR 214.55	Generic · Prescription	SPIMACO ADDWAEIH	Valid
LAGONA 5 mg Hard capsule	5 mg	Capsule, hard · Oral use	5 Sachet	SAR 53.65	Generic · Prescription	SPIMACO ADDWAEIH	Valid
LAGONA 5 mg Hard capsule	5 mg	Capsule, hard · Oral use	20 Sachet	SAR 214.55	Generic · Prescription	SPIMACO ADDWAEIH	Valid
TEGOZOL 100 mg Capsule	100 mg	Capsule · Oral use	5 Bottle	SAR 1096.70	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
TEGOZOL 20 mg Capsule	20 mg	Capsule · Oral use	5 Bottle	SAR 231.25	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
TEGOZOL 250 mg Capsule	250 mg	Capsule · Oral use	5 Bottle	SAR 2970.25	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Zolomid	20 mg	Capsule, hard · Oral use	5 Sachet	SAR 226.50	Generic · Prescription	Eva Pharma for Pharmaceuticals & Medical Appliances	Valid
Zolomid	100 mg	Capsule, hard · Oral use	5 Sachet	SAR 1074.05	Generic · Prescription	Eva Pharma for Pharmaceuticals & Medical Appliances	Valid
LAGONA 140 mg Hard capsule	140 mg	Capsule, hard · Oral use	5 Sachet	SAR 1366.15	NCE · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
LAGONA 140 mg Hard capsule	140 mg	Capsule, hard · Oral use	20 Sachet	SAR 5464.60	NCE · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
LAGONA 180 mg Hard capsule	180 mg	Capsule, hard · Oral use	5 Sachet	SAR 1460.40	NCE · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
LAGONA 180 mg Hard capsule	180 mg	Capsule, hard · Oral use	20 Sachet	SAR 5841.60	NCE · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
LAGONA 20 mg Hard capsule	20 mg	Capsule, hard · Oral use	20 Sachet	SAR 953.60	NCE · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
LAGONA 250 mg Hard capsule	250 mg	Capsule, hard · Oral use	5 Sachet	SAR 3062.10	NCE · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
LAGONA 250 mg Hard capsule	250 mg	Capsule, hard · Oral use	20 Sachet	SAR 12248.40	NCE · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
TEMOL 100 mg capsule	100 mg	Capsule, hard · Oral use	5 Sachet	SAR 1330.15	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Withdrawn by MAH · Not Marketed
TEMOL 140 mg capsule	140 mg	Capsule, hard · Oral use	5 Sachet	SAR 1607.25	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Withdrawn by MAH · Not Marketed
TEMOL 180 mg capsule	180 mg	Capsule, hard · Oral use	5 Sachet	SAR 1718.10	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Withdrawn by MAH · Not Marketed
TEMOL 20 mg capsule	20 mg	Capsule, hard · Oral use	5 Sachet	SAR 280.45	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Withdrawn by MAH · Not Marketed
TEMOL 250 mg capsule	250 mg	Capsule, hard · Oral use	5 Sachet	SAR 3602.50	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACROMEGALY; BONE SARCOMAS; BRAIN CANCERS; HYPERPROLACTINEMIA; MELANOMA; Neuroblastoma; NEUROENDOCRINE TUMORS; SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
TEMODAR	100MG/VIAL	powder · intravenous	MERCK SHARP DOHME	Prescription	27 Feb 2009
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	SUN PHARM	Prescription	12 Feb 2014
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	AMNEAL PHARMS	Prescription	8 May 2015
TEMOZOLOMIDE	100MG; 140MG; 180MG; 250MG	capsule · oral	EIRGEN	Prescription	10 Feb 2016
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	CHARTWELL	Prescription	12 Apr 2016
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	RISING	Prescription	27 Apr 2016
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	CHEMI SPA	Prescription	23 Nov 2016
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	ACCORD HLTHCARE	Prescription	27 Feb 2017
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	DEVA HOLDING AS	Prescription	26 Apr 2017
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	ZYDUS PHARMS	Prescription	31 Jul 2017
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	HETERO LABS LTD V	Prescription	23 Aug 2024
TEMODAR	5MG; 20MG; 100MG; 250MG; 140MG; 180MG	capsule · oral	MERCK SHARP DOHME	Discontinued	11 Aug 1999
TEMOZOLOMIDE	5MG; 20MG; 100MG; 250MG; 140MG; 180MG	capsule · oral	HERITAGE	Discontinued	1 Mar 2010
TEMOZOLOMIDE	5MG; 20MG	capsule · oral	EIRGEN	Discontinued	10 Feb 2016
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	PHARMAZONE	Discontinued	29 Jun 2016
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	ANI PHARMS	Discontinued	13 Jul 2016
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 250MG	capsule · oral	WATSON LABS TEVA	Discontinued	18 Apr 2017
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	APOTEX	Discontinued	5 Jul 2018
TEMOZOLOMIDE	5MG; 20MG; 100MG; 140MG; 180MG; 250MG	capsule · oral	NIVAGEN	Discontinued	23 Nov 2021

EMA European Union — centrally authorised medicines

Temodal Merck Sharp & Dohme B.V. · Authorised · authorised 26 Jan 1999 · ATC L01AX03

Therapeutic indication (EMA)

Temodal hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Temomedac medac Gesellschaft für klinische Spezialpräparate mbH · Authorised · authorised 25 Jan 2010 · ATC L01AX03

Therapeutic indication (EMA)

Temomedac hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Temozolomide Teva Teva B.V. · Authorised · authorised 28 Jan 2010 · ATC L01AX03

Therapeutic indication (EMA)

For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Temozolomide Accord Accord Healthcare S.L.U. · Authorised · authorised 15 Mar 2010 · ATC L01AX03

Therapeutic indication (EMA)

Temozolomide Sun Sun Pharmaceutical Industries Europe B.V. · Authorised · authorised 13 Jul 2011 · ATC L01AX03

Therapeutic indication (EMA)

Temozolomide Sun is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Kizfizo ORPHELIA Pharma · Refused · ATC L01AX03

Therapeutic indication (EMA)

Treatment of neuroblastoma.

Temozolomide Hexal Hexal AG · Withdrawn · authorised 15 Mar 2010 · ATC L01AX03

Therapeutic indication (EMA)

Temozolomide Sandoz Sandoz GmbH · Withdrawn · authorised 15 Mar 2010 · ATC L01AX03

Therapeutic indication (EMA)

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-TEMOZOLOMIDE	02389819	20 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
ACH-TEMOZOLOMIDE	02389827	100 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
ACH-TEMOZOLOMIDE	02389835	140 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
ACH-TEMOZOLOMIDE	02389851	250 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
ACH-TEMOZOLOMIDE	02438119	5 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
JAMP TEMOZOLOMIDE	02516799	5 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP TEMOZOLOMIDE	02516802	20 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP TEMOZOLOMIDE	02516810	100 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP TEMOZOLOMIDE	02516829	140 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP TEMOZOLOMIDE	02516845	250 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
TARO-TEMOZOLOMIDE	02443473	5 MG	CAPSULE · ORAL	TARO PHARMACEUTICALS INC
TARO-TEMOZOLOMIDE	02443481	20 MG	CAPSULE · ORAL	TARO PHARMACEUTICALS INC
TARO-TEMOZOLOMIDE	02443511	100 MG	CAPSULE · ORAL	TARO PHARMACEUTICALS INC
TARO-TEMOZOLOMIDE	02443538	140 MG	CAPSULE · ORAL	TARO PHARMACEUTICALS INC
TARO-TEMOZOLOMIDE	02443554	250 MG	CAPSULE · ORAL	TARO PHARMACEUTICALS INC
TEMODAL	02241093	5 MG	CAPSULE · ORAL	MERCK CANADA INC
TEMODAL	02241094	20 MG	CAPSULE · ORAL	MERCK CANADA INC
TEMODAL	02241095	100 MG	CAPSULE · ORAL	MERCK CANADA INC
TEMODAL	02241096	250 MG	CAPSULE · ORAL	MERCK CANADA INC
TEMODAL	02312794	140 MG	CAPSULE · ORAL	MERCK CANADA INC
TEVA-TEMOZOLOMIDE	02395274	20 MG	CAPSULE · ORAL	TEVA CANADA LIMITED
TEVA-TEMOZOLOMIDE	02395282	100 MG	CAPSULE · ORAL	TEVA CANADA LIMITED
TEVA-TEMOZOLOMIDE	02395290	140 MG	CAPSULE · ORAL	TEVA CANADA LIMITED
TEVA-TEMOZOLOMIDE	02395312	250 MG	CAPSULE · ORAL	TEVA CANADA LIMITED
TEVA-TEMOZOLOMIDE	02441160	5 MG	CAPSULE · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TEMOZOLOMIDE 100 MG CAPSULE	$4.37549	per EA	23 Sep 2026
US NADAC	TEMOZOLOMIDE 20 MG CAPSULE	$0.87977	per EA	23 Sep 2026
US NADAC	TEMOZOLOMIDE 250 MG CAPSULE	$20.5332	per EA	22 Oct 2025

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 14 Sep 2023 TEMODAR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 Sep 2023 TEMODAR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 29 Sep 2022 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
EMA PRAC 10 Jun 2022 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
EMA PRAC 14 Jun 2019 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: Yes
EMA PRAC 17 Jan 2019 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No
EMA PRAC 6 Apr 2017 PRAC signal: Meningoencephalitis herpetic
Action for MAH: update of the product information: Yes
EMA PRAC 1 Dec 2016 PRAC signal: Meningoencephalitis herpetic
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Temozolomide: risk of hepatic injury, including fatal hepatic failure—updated warnings and monitoring guidance
Liver function should be tested before and during treatment with temozolomide.
EMA PRAC 11 Sep 2014 PRAC signal: Dehydration leading to renal failure
Action for MAH: update of the product information: No
EMA PRAC 8 May 2014 PRAC signal: Diabetes insipidus
Action for MAH: update of the product information: No
EMA PRAC 7 Mar 2013 PRAC signal: Hepatic failure
Action for MAH: update of the product information: Yes
EMA PRAC 3 Oct 2012 PRAC signal: Hepatic failure
Action for MAH: update of the product information: No

All safety entries for temozolomide →

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.