TEPADINA

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Spain, Turkey, UK.

Active ingredients

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

1
UNII 905Z5W3GKH - THIOTEPA
 

Thiotepa is a polyfunctional cytotoxic agent related chemically and pharmacologically to the nitrogen mustard. The radiomimetic action of thiotepa is believed to occur through the release of ethylene imine radicals that, as in the case of irradiation therapy, disrupt the bonds of DNA, e.g. by alkylation of guanine at the N-7, breaking the linkage between the purine base and the sugar and liberating alkylated guanine.

 
Read more about Thiotepa

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 TEPADINA Powder for concentrate 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
L01AC01 Thiotepa L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01A Alkylating agents → L01AC Ethylene imines
Discover more medicines within L01AC01

Authorization and marketing

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

Country Identification scheme Identifier(s)
CA Health Products and Food Branch 02462680, 02462702
EE Ravimiamet 1462193, 1462205, 1845963
ES Centro de información online de medicamentos de la AEMPS 10622001, 10622002
FI Lääkealan turvallisuus- ja kehittämiskeskus 038822, 089079, 423204
FR Base de données publique des médicaments 60177724, 65410278
GB Medicines & Healthcare Products Regulatory Agency 193118, 193124, 394052
HK Department of Health Drug Office 63411, 63412
IL מִשְׂרַד הַבְּרִיאוּת 7761, 7762
IT Agenzia del Farmaco 039801016, 039801028, 039801030
LT Valstybinė vaistų kontrolės tarnyba 1053740, 1053741, 1082315, 1088470, 1092420
NL Z-Index G-Standaard, PRK 94102, 94110
PL Rejestru Produktów Leczniczych 100252721, 100252738
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W66786001, W66787001, W67921001
TR İlaç ve Tıbbi Cihaz Kurumu 8699783770396
US FDA, National Drug Code 70121-1630, 70121-1631

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