Inotuzumab ozogamicin

Besponsa 1 mg, poeder voor concentraat voor oplossing voor infusie

Poeder voor concentraat voor oplossing voor infusieNetherlandsAuthorisedAuthorised 29 Jun 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.

BesponsaEuropean UnionAuthorised

BesponsaBrazil · Pfizer Brasil LtdaSame brand
BesponsaCanada · 0.9 MG / VIAL · Powder For Solution · Pfizer Canada UlcSame brand
Besponsa 1 MG Polvo Para Concentrado Para Solucion Para PerfusionSpain · 1 mg · polvo para concentrado para solución para perfusión · Pfizer Europe Ma EeigSame brand
BesponsaEuropean Union · Pfizer Europe MA EEIGSame brand
BesponsaCroatiaSame brand
BesponsaItaly · polvere per concentrato e soluzione per soluzione per infusione · Pfizer Europe Ma Eeig

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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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Inotuzumab ozogamicin

Besponsa 1 mg, poeder voor concentraat voor oplossing voor infusie

Poeder voor concentraat voor oplossing voor infusieNetherlandsAuthorisedAuthorised 29 Jun 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.

BesponsaEuropean UnionAuthorised

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

BesponsaNew Zealand · Inj 1 mg vial

BESPONSA 1 mgRomania · 1mg · pulb. pt. conc. pt. sol. perf. · Pfizer Europe Ma Eeig

Besponsa®Serbia · 1mg · prašak za koncentrat za rastvor za infuziju · Pfizer SRB D.O.O.

BESPONSA 0.9 mg VialSaudi Arabia · Wyeth

Besponsa Powder for Concentrate for Solution for Infusion 1MG/VialSingapore · 1mg/vial · powder, for solution · Pfizer Private Limited

BesponsaUnited States · 0.9/MG/VIAL · powder, for injection solution, lyophilized powder · Wyeth Pharms INC

Documents

The official texts, at the regulator.

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: Inotuzumab ozogamicin
Dosage form: Poeder voor concentraat voor oplossing voor infusie
Route: Intraveneus gebruik
Register: Netherlands (CBG-MEB)
Status: Authorised
Status in the register: Ingeschreven
Authorised: 29 Jun 2017
Registration: EU/1/17/1200
Marketing authorisation holder: Pfizer Europe MA EEIG
ATC code: L01FB01
Group: Antineoplastic and immunomodulating agents
Procedure: EU centralised
Supply: Uitsluitend recept
EMA product number: EMEA/H/C/004119
EU number: EU/1/17/1200