This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, 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
The drug IMFINZI contains one active pharmaceutical ingredient (API):
1
Durvalumab
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. |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
IMFINZI Concentrate for solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC code | Group title | 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 |
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): 11911X, 11915D |
Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 502318050033502, 502318050033602 |
Country: CA | Health Products and Food Branch | Identifier(s): 02468816 |
Country: EE | Ravimiamet | Identifier(s): 1769575, 1780602, 1780635, 1849899 |
Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 1181322001, 1181322001IP, 1181322002, 1181322002IP |
Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 034118, 382578 |
Country: FR | Base de données publique des médicaments | Identifier(s): 63690956 |
Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 358756, 358760 |
Country: HK | Department of Health Drug Office | Identifier(s): 65928, 65929 |
Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8291, 8292 |
Country: IT | Agenzia del Farmaco | Identifier(s): 047089014, 047089026 |
Country: JP | 医薬品医療機器総合機構 | Identifier(s): 4291443A1023, 4291443A2020 |
Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1086422, 1086423 |
Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 196029, 196037 |
Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 20513, 20514 |
Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100411705 |
Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W64923001, W64923002 |
Country: SG | Health Sciences Authority | Identifier(s): 15569P |
Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699786770805, 8699786770904 |
Country: US | FDA, National Drug Code | Identifier(s): 0310-4500, 0310-4611 |
Country: ZA | Health Products Regulatory Authority | Identifier(s): 54/30.1/0001, 54/30.1/0002 |
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