This brand name is authorized in Austria, Canada, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, New Zealand, Poland, Romania, United Kingdom, United States
The drug POLIVY contains one active pharmaceutical ingredient (API):
1
Polatuzumab vedotin
UNII KG6VO684Z6 - POLATUZUMAB VEDOTIN
|
Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells. MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis. |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
POLIVY Powder for concentrate for solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC | |
POLIVY Powder for solution for injection | FDA, National Drug Code (US) | MPI, US: SPL/PLR |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC code | Group title | Classification |
---|---|---|
L01FX14 | Polatuzumab vedotin | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FX Other monoclonal antibodies |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
---|---|---|
Country: CA | Health Products and Food Branch | Identifier(s): 02499614 |
Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 186-MBE-0421, 210-MBE-0821 |
Country: EE | Ravimiamet | Identifier(s): 1810099, 1834051 |
Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 112212, 471385 |
Country: FR | Base de données publique des médicaments | Identifier(s): 60380094, 60978348 |
Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 382216, 393295 |
Country: HK | Department of Health Drug Office | Identifier(s): 66664, 67107 |
Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8528 |
Country: IT | Agenzia del Farmaco | Identifier(s): 048443016, 048443028 |
Country: JP | 医薬品医療機器総合機構 | Identifier(s): 4291455D1022, 4291455D2029 |
Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1089249, 1091495 |
Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 20697 |
Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100430720, 100456900 |
Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W66558001, W67121001 |
Country: US | FDA, National Drug Code | Identifier(s): 50242-103, 50242-105 |
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