ZELBORAF

This brand name is authorized in United States. It is also authorized in Australia, 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, Tunisia, Turkey, UK.

Active ingredients

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

1	Vemurafenib UNII 207SMY3FQT - VEMURAFENIB
	Vemurafenib is an inhibitor of BRAF serine-threonine kinase. Mutations in the BRAF gene result in constitutive activation of BRAF proteins, which can cause cell proliferation without associated growth factors. Before taking vemurafenib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test.
	Read more about Vemurafenib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ZELBORAF 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
L01EC01	Vemurafenib	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EC B-Raf serine-threonine kinase (BRAF) inhibitors
Discover more medicines within L01EC01

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	11076Y, 11081F
BR	Câmara de Regulação do Mercado de Medicamentos	529212050024102
CA	Health Products and Food Branch	02380242
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	360430612
EE	Ravimiamet	1556771
ES	Centro de información online de medicamentos de la AEMPS	12751001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	438759
FR	Base de données publique des médicaments	66271123
GB	Medicines & Healthcare Products Regulatory Agency	201064
HK	Department of Health Drug Office	61970
IE	Health Products Regulatory Authority	88248
IL	מִשְׂרַד הַבְּרִיאוּת	6933
IT	Agenzia del Farmaco	041863010
JP	医薬品医療機器総合機構	4291037F1022
LT	Valstybinė vaistų kontrolės tarnyba	1065140, 1084025
NL	Z-Index G-Standaard, PRK	101176
NZ	Medicines and Medical Devices Safety Authority	15045
PL	Rejestru Produktów Leczniczych	100268030
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64409001
SG	Health Sciences Authority	14308P
TN	Direction de la Pharmacie et du Médicament	6993251H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699505092560
US	FDA, National Drug Code	50242-090
ZA	Health Products Regulatory Authority	47/32.16/0247