RYDAPT

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, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Turkey, UK.

Active ingredients

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

1
UNII ID912S5VON - MIDOSTAURIN
 

Midostaurin inhibits multiple receptor tyrosine kinases, including FLT3 and KIT kinase. Midostaurin inhibits FLT3 receptor signalling and induces cell cycle arrest and apoptosis in leukaemic cells expressing FLT3 ITD or TKD mutant receptors or over-expressing FLT3 wild type receptors.

 
Read more about Midostaurin

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 RYDAPT Soft 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
L01EX10 L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EX Other protein kinase inhibitors
Discover more medicines within L01EX10

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 11505M, 11506N, 11518F, 11531X, 11552B, 11553C
BR Câmara de Regulação do Mercado de Medicamentos 526518080094101
EE Ravimiamet 1753769, 1764794
ES Centro de información online de medicamentos de la AEMPS 1171218001
FI Lääkealan turvallisuus- ja kehittämiskeskus 500476, 519755
FR Base de données publique des médicaments 67868413
GB Medicines & Healthcare Products Regulatory Agency 353634
HK Department of Health Drug Office 65725
IE Health Products Regulatory Authority 89103
IL מִשְׂרַד הַבְּרִיאוּת 8106, 8107
IT Agenzia del Farmaco 045612013, 045612025
LT Valstybinė vaistų kontrolės tarnyba 1083947, 1084937
NL Z-Index G-Standaard, PRK 148016
NZ Medicines and Medical Devices Safety Authority 20639
PL Rejestru Produktów Leczniczych 100392385
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W64447001
SG Health Sciences Authority 15518P
TR İlaç ve Tıbbi Cihaz Kurumu 8699504190151
US FDA, National Drug Code 0078-0698

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