STIVARGA

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

Active ingredients

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

1 Regorafenib
UNII MGN125FS9D - REGORAFENIB

Regorafenib is an oral tumour deactivation agent that potently blocks multiple protein kinases, including kinases involved in tumour angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E), metastasis (VEGFR3, PDGFR, FGFR) and tumour immunity (CSF1R). Regorafenib inhibits mutated KIT, a major oncogenic driver in gastrointestinal stromal tumours, and thereby blocks tumour cell proliferation.

Read about Regorafenib

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
STIVARGA Film-coated tablet 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
L01EX05 L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EX Other protein kinase inhibitors
Discover more medicines within L01EX05

Authorization and marketing

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

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 538916050026901, 538916050027001
Country: CA Health Products and Food Branch Identifier(s): 02403390
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): H4890513
Country: EE Ravimiamet Identifier(s): 1624171, 1624182
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 113858002
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 190054
Country: FR Base de données publique des médicaments Identifier(s): 69548508
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 232694, 368978
Country: HK Department of Health Drug Office Identifier(s): 63304
Country: IE Health Products Regulatory Authority Identifier(s): 88493
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 7404
Country: JP 医薬品医療機器総合機構 Identifier(s): 4291029F1028
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1071161, 1071162
Country: NL Z-Index G-Standaard, PRK Identifier(s): 107115
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 16246
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100304240
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W64833001, W64833002
Country: SG Health Sciences Authority Identifier(s): 14360P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699546090303
Country: US FDA, National Drug Code Identifier(s): 50419-171
Country: ZA Health Products Regulatory Authority Identifier(s): 47/26/1005

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