STIVARGA

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, 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: IT	Agenzia del Farmaco	Identifier(s): 042925014, 042925026
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