STIVARGA

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

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 more about Regorafenib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
STIVARGA Film-coated tablet	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
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)
BR	Câmara de Regulação do Mercado de Medicamentos	538916050026901, 538916050027001
CA	Health Products and Food Branch	02403390
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	H4890513
EE	Ravimiamet	1624171, 1624182
ES	Centro de información online de medicamentos de la AEMPS	113858002
FI	Lääkealan turvallisuus- ja kehittämiskeskus	190054
FR	Base de données publique des médicaments	69548508
GB	Medicines & Healthcare Products Regulatory Agency	232694, 368978
HK	Department of Health Drug Office	63304
IE	Health Products Regulatory Authority	88493
IL	מִשְׂרַד הַבְּרִיאוּת	7404
IT	Agenzia del Farmaco	042925014, 042925026
JP	医薬品医療機器総合機構	4291029F1028
LT	Valstybinė vaistų kontrolės tarnyba	1071161, 1071162
NL	Z-Index G-Standaard, PRK	107115
NZ	Medicines and Medical Devices Safety Authority	16246
PL	Rejestru Produktów Leczniczych	100304240
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64833001, W64833002
SG	Health Sciences Authority	14360P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699546090303
US	FDA, National Drug Code	50419-171
ZA	Health Products Regulatory Authority	47/26/1005