IMFINZI

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, 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 IMFINZI contains one active pharmaceutical ingredient (API):

1
UNII 28X28X9OKV - DURVALUMAB
 

Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that selectively blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1). Durvalumab does not induce antibody dependent cell-mediated cytotoxicity (ADCC). Selective blockade of PD-L1/PD-1 and PD-L1/CD80 interactions enhances antitumour immune responses and increases T-cell activation.

 
Read more about Durvalumab

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 IMFINZI Concentrate for solution for infusion 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
L01FF03 Durvalumab L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FF PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors
Discover more medicines within L01FF03

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 11911X, 11915D
BR Câmara de Regulação do Mercado de Medicamentos 502318050033502, 502318050033602
CA Health Products and Food Branch 02468816
EE Ravimiamet 1769575, 1780602, 1780635, 1849899
ES Centro de información online de medicamentos de la AEMPS 1181322001, 1181322001IP, 1181322002, 1181322002IP
FI Lääkealan turvallisuus- ja kehittämiskeskus 034118, 382578
FR Base de données publique des médicaments 63690956
GB Medicines & Healthcare Products Regulatory Agency 358756, 358760
HK Department of Health Drug Office 65928, 65929
IL מִשְׂרַד הַבְּרִיאוּת 8291, 8292
IT Agenzia del Farmaco 047089014, 047089026
JP 医薬品医療機器総合機構 4291443A1023, 4291443A2020
LT Valstybinė vaistų kontrolės tarnyba 1086422, 1086423
NL Z-Index G-Standaard, PRK 196029, 196037
NZ Medicines and Medical Devices Safety Authority 20513, 20514
PL Rejestru Produktów Leczniczych 100411705
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W64923001, W64923002
SG Health Sciences Authority 15569P
TR İlaç ve Tıbbi Cihaz Kurumu 8699786770805, 8699786770904
US FDA, National Drug Code 0310-4500, 0310-4611
ZA Health Products Regulatory Authority 54/30.1/0001, 54/30.1/0002

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