This brand name is authorized in Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, United Kingdom, United States
The drug ZINPLAVA contains one active pharmaceutical ingredient (API):
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1
Bezlotoxumab
UNII 4H5YMK1H2E - BEZLOTOXUMAB
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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. |
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 |
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 | |
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: IT | Agenzia del Farmaco | Identifier(s): 045252018 |
| 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 |
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