POLIVY

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, New Zealand, Poland, Romania, UK.

Active ingredients

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

1
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.

 
Read more about Polatuzumab vedotin

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 POLIVY Powder for concentrate for solution for infusion MPI, EU: SmPC European Medicines Agency (EU)
 POLIVY Powder for solution for injection MPI, US: SPL/PLR FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
L01FX14 Polatuzumab vedotin L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FX Other monoclonal antibodies
Discover more medicines within L01FX14

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
CA Health Products and Food Branch 02499614
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 186-MBE-0421, 210-MBE-0821
EE Ravimiamet 1810099, 1834051
FI Lääkealan turvallisuus- ja kehittämiskeskus 112212, 471385
FR Base de données publique des médicaments 60380094, 60978348
GB Medicines & Healthcare Products Regulatory Agency 382216, 393295
HK Department of Health Drug Office 66664, 67107
IL מִשְׂרַד הַבְּרִיאוּת 8528
IT Agenzia del Farmaco 048443016, 048443028
JP 医薬品医療機器総合機構 4291455D1022, 4291455D2029
LT Valstybinė vaistų kontrolės tarnyba 1089249, 1091495
NZ Medicines and Medical Devices Safety Authority 20697
PL Rejestru Produktów Leczniczych 100430720, 100456900
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W66558001, W67121001
US FDA, National Drug Code 50242-103, 50242-105

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