ZINPLAVA

This brand name is authorized in Austria, Estonia, Spain, Finland, France, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, United Kingdom, United States

Active ingredients

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

1 Bezlotoxumab UNII 4H5YMK1H2E - BEZLOTOXUMAB

Bezlotoxumab is a human monoclonal antitoxin antibody that binds with high affinity to C. difficile toxin B and neutralizes its activity. Bezlotoxumab prevents CDI recurrence by providing passive immunity against toxin produced by the outgrowth of persistent or newly-acquired C. difficile spores. Read about Bezlotoxumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ZINPLAVA Concentrate for solution for infusion	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
J06BC03		J Antiinfectives for systemic use → J06 Immune sera and immunoglobulins → J06B Immunoglobulins → J06BC Antibacterial monoclonal antibodies
Discover more medicines within J06BC03

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 1737075
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1161156001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 037941
Country: FR	Base de données publique des médicaments	Identifier(s): 69894104
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 345433
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8557
Country: JP	医薬品医療機器総合機構	Identifier(s): 6399426A1022
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1081971
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 139661
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100383883
Country: US	FDA, National Drug Code	Identifier(s): 0006-3025