TEMODAL

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

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 about Temozolomide

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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