TEMODAL

This brand name is authorized in Australia, Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

The drug TEMODAL contains one active pharmaceutical ingredient (API):

1	Temozolomide UNII YF1K15M17Y - TEMOZOLOMIDE
	Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC). The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position. Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct.
	Read more about Temozolomide

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TEMODAL Hard capsule	MPI, EU: SmPC	European Medicines Agency (EU)
TEMODAL Powder for solution for infusion	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
L01AX03	Temozolomide	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01A Alkylating agents → L01AX Other alkylating agents
Discover more medicines within L01AX03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	10062N, 2438H, 8380C, 8381D, 8821G, 9361Q, 9362R
BR	Câmara de Regulação do Mercado de Medicamentos	527313070010314, 527314090014403, 527314090014503, 527314090014603, 527314090014703, 527314090014803, 527314090014903
CA	Health Products and Food Branch	02241093, 02241094, 02241095, 02241096, 02312794
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	05548719, 05548754, 05548777, 05548808, 05548814, 05549073, 05549802, 06140713, 06140736, 06570106, 07319555, 07319578, 07319615, 07319644, 07319650, 07319710, 10990825, 10992014, 11158224, 12392732, 13351824, 13351853, 13982648, 16147082, 16873256
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	27.458-1-01-12, 27.460-1-01-12
EE	Ravimiamet	1114951, 1114962, 1114973, 1114984, 1114995, 1115008, 1115019, 1115020, 1303232, 1303243, 1303254, 1303265, 1422627
ES	Centro de información online de medicamentos de la AEMPS	98096013, 98096015, 98096017, 98096019, 98096024
FI	Lääkealan turvallisuus- ja kehittämiskeskus	029912, 031303, 031325
FR	Base de données publique des médicaments	60914573, 61030104, 61710965, 62188712, 66254857, 68196114, 68740943
GB	Medicines & Healthcare Products Regulatory Agency	164556, 164557, 164558, 164561, 164562, 164563
HK	Department of Health Drug Office	53858, 53859, 53860, 53861
IE	Health Products Regulatory Authority	88192, 88198, 88203, 88204, 88215, 88253
IL	מִשְׂרַד הַבְּרִיאוּת	4193, 4194, 4195, 4196
IT	Agenzia del Farmaco	034527135, 034527150, 034527174, 034527198, 034527212
JP	医薬品医療機器総合機構	4219004M1024, 4219004M2020, 4219404D1027
LT	Valstybinė vaistų kontrolės tarnyba	1011316, 1011317, 1011318, 1011319, 1011320, 1011321, 1011322, 1011323, 1031083, 1031084, 1031085, 1036527, 1036528, 1036529, 1036530, 1036531, 1036532, 1036533, 1036534, 1036535, 1036536, 1036537, 1036538, 1064330, 1064331
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	210M99
NL	Z-Index G-Standaard, PRK	52310, 52329, 52337
PL	Rejestru Produktów Leczniczych	100095463, 100095470, 100095486, 100095492, 100112345, 100158258, 100162886
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W59615001, W59615002, W59615003, W59615004, W64827001, W64827002, W64827003, W64827004, W64828001, W64828002, W64828003, W64828004
SG	Health Sciences Authority	11706P, 11707P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699636150504, 8699636150511, 8699636150528, 8699636150535, 8699636150542, 8699636150559
ZA	Health Products Regulatory Authority	32/26/0721, 32/26/0722, 32/26/0723, 32/26/0724, 42/26/0961, 42/26/0962