en

PRODUCT DETAIL

ZINPLAVA 25 mg/ml koncentrát na infúzny roztok

Code 3039C
MA number EU/1/16/1156/001
Product Form: con inf 1x40 ml/1000 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J06 IMMUNE SERA AND IMMUNOGLOBULINS
J06B IMMUNOGLOBULINS
J06BC Antibacterial monoclonal antibodies
J06BC03 Bezlotoxumab
Shelf life: 36
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 18.01.2017
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 22.05.2023
eu-flag.png sk-flag.png