ZINPLAVA

This brand name is authorized in United States. It is also authorized in Austria, Croatia, Estonia, Finland, France, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Spain, UK.

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 more about Bezlotoxumab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ZINPLAVA 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
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)
EE	Ravimiamet	1737075
ES	Centro de información online de medicamentos de la AEMPS	1161156001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	037941
FR	Base de données publique des médicaments	69894104
GB	Medicines & Healthcare Products Regulatory Agency	345433
IL	מִשְׂרַד הַבְּרִיאוּת	8557
IT	Agenzia del Farmaco	045252018
JP	医薬品医療機器総合機構	6399426A1022
LT	Valstybinė vaistų kontrolės tarnyba	1081971
NL	Z-Index G-Standaard, PRK	139661
PL	Rejestru Produktów Leczniczych	100383883
US	FDA, National Drug Code	0006-3025