ZELBORAF

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

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 about Vemurafenib

Medication package inserts

Below package inserts are available for further reading:

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