HYCAMTIN

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

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

1
UNII 956S425ZCY - TOPOTECAN HYDROCHLORIDE
 

Topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication.

 
Read more about Topotecan

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 HYCAMTIN Powder for concentrate for solution for infusion MPI, EU: SmPC European Medicines Agency (EU)
 HYCAMTIN Hard capsule 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
L01CE01 Topotecan L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01C Plant alkaloids and other natural products → L01CE Topoisomerase 1 (TOP1) inhibitors
Discover more medicines within L01CE01

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 4617B, 7260D
BR Câmara de Regulação do Mercado de Medicamentos 526517080090317
EE Ravimiamet 1044627, 1071076, 1213748, 1213759, 1364598, 1364600
ES Centro de información online de medicamentos de la AEMPS 96027001, 96027006, 96027007
FI Lääkealan turvallisuus- ja kehittämiskeskus 126374, 126385
FR Base de données publique des médicaments 61126871, 63093822, 63901015
GB Medicines & Healthcare Products Regulatory Agency 142260, 142263, 48028, 73158
HK Department of Health Drug Office 41723, 57841, 57842
IE Health Products Regulatory Authority 88560, 88585
IL מִשְׂרַד הַבְּרִיאוּת 3401, 6352
JP 医薬品医療機器総合機構 4240408D1037
LT Valstybinė vaistų kontrolės tarnyba 1003757, 1003758, 1004910, 1004911, 1006524, 1028878, 1089213
NL Z-Index G-Standaard, PRK 46442, 87181, 87203
PL Rejestru Produktów Leczniczych 100094363, 100137977, 100192410, 100192427
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W64499001
SG Health Sciences Authority 09415P, 13707P, 13708P
TR İlaç ve Tıbbi Cihaz Kurumu 8699504790900, 8699504790917
US FDA, National Drug Code 0078-0672, 0078-0673, 0078-0674
ZA Health Products Regulatory Authority 31/26/0300, 42/26/0740

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