SUTENT

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

Active ingredients

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

1
UNII LVX8N1UT73 - SUNITINIB MALATE
 

Sunitinib inhibits multiple RTKs that are implicated in tumour growth, neoangiogenesis, and metastatic progression of cancer.

 
Read more about Sunitinib

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 SUTENT 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
L01EX01 Sunitinib L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EX Other protein kinase inhibitors
Discover more medicines within L01EX01

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 10004M, 10009T, 10010W, 10459L, 10464R, 10473F, 10503T, 10504W, 11250D, 11253G, 11256K, 11266Y, 2837H, 2842N, 2959R, 9417P, 9418Q, 9419R, 9420T, 9421W, 9422X, 9488J, 9489K, 9490L
BR Câmara de Regulação do Mercado de Medicamentos 522720050087617, 522720050087717, 522720050087817
CA Health Products and Food Branch 02280795, 02280809, 02280817
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 27.733-06-07, 27.734-1-03-12, 27.738-06-07
EE Ravimiamet 1257982, 1257993, 1258006, 1353282, 1353293, 1353305, 1426632, 1426643
ES Centro de información online de medicamentos de la AEMPS 06347001, 06347002, 06347003
FI Lääkealan turvallisuus- ja kehittämiskeskus 099863, 099872, 099881
FR Base de données publique des médicaments 63841059, 65283820, 69225978
GB Medicines & Healthcare Products Regulatory Agency 136358, 136363, 136365
HK Department of Health Drug Office 55404, 55405, 55406, 59785
IE Health Products Regulatory Authority 88684, 88685, 88686
IL מִשְׂרַד הַבְּרִיאוּת 6045, 6046, 6047
IT Agenzia del Farmaco 037192010, 037192022, 037192034
JP 医薬品医療機器総合機構 4291018M1029
LT Valstybinė vaistų kontrolės tarnyba 1030588, 1030589, 1030590, 1030591, 1030592, 1030593, 1038372, 1038373, 1060892, 1061423
MX Comisión Federal para la Protección contra Riesgos Sanitarios 233M2006
NL Z-Index G-Standaard, PRK 83453, 83461, 83488
NZ Medicines and Medical Devices Safety Authority 12700, 12701, 12702, 17938
PL Rejestru Produktów Leczniczych 100114829, 100116923, 100118520, 100214933
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W65026001, W65027001, W65028001
SG Health Sciences Authority 13254P, 13255P, 13256P, 13920P
TN Direction de la Pharmacie et du Médicament 8013061H, 8013062H, 8013063H
TR İlaç ve Tıbbi Cihaz Kurumu 8681308157553, 8681308158994, 8681308159427, 8681308159434, 8681308159571
US FDA, National Drug Code 0069-0550, 0069-0770, 0069-0830, 0069-0980
ZA Health Products Regulatory Authority 41/26/0195, 41/26/0196

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