Bezlotoxumab

ZINPLAVA 25 mg/ml, concentraat voor oplossing voor infusie

Concentraat voor oplossing voor infusieNetherlandsAuthorisedAuthorised 18 Jan 2017

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In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

ZinplavaEuropean UnionAuthorised

Zinplava 25 MG/ML Concentrado Para Solucion Para PerfusionSpain · 1000 mg · concentrado para solución para perfusión · Merck Sharp & Dohme B.V.Same brand
ZinplavaEuropean Union · Merck Sharp & Dohme B.V.Same brand
ZinplavaCroatiaSame brand
ZinplavaUnited States · 1000ML/40ML · injectable · Merck Sharp DohmeSame brand

Documents

The official texts, at the regulator.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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Bezlotoxumab

ZINPLAVA 25 mg/ml, concentraat voor oplossing voor infusie

Concentraat voor oplossing voor infusieNetherlandsAuthorisedAuthorised 18 Jan 2017

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

ZinplavaEuropean UnionAuthorised

Documents

The official texts, at the regulator.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Summary of product characteristicsCBG-MEB

Register entryCBG-MEB

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

College ter Beoordeling van Geneesmiddelen

College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.

Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim · Added 8 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Bezlotoxumab
Dosage form: Concentraat voor oplossing voor infusie
Route: Intraveneus gebruik
Register: Netherlands (CBG-MEB)
Status: Authorised
Status in the register: Ingeschreven
Authorised: 18 Jan 2017
Registration: EU/1/16/1156
Marketing authorisation holder: Merck Sharp & Dohme B.V.
ATC code: J06BC03
Group: Anti-infectives for systemic use
Procedure: EU centralised
Supply: Uitsluitend recept
EMA product number: EMEA/H/C/004136
EU number: EU/1/16/1156