Inotuzumab ozogamicin

Besponsa 1 MG Polvo Para Concentrado Para Solucion Para Perfusion

1 mg polvo para concentrado para solución para perfusiónSpainMarketedAuthorised 21 Jul 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
BesponsaEuropean Union · Pfizer Europe MA EEIGSame brand
BesponsaCroatiaSame brand
BesponsaItaly · polvere per concentrato e soluzione per soluzione per infusione · Pfizer Europe Ma EeigSame brand
Besponsa 1 mg, poeder voor concentraat voor oplossing voor infusieNetherlands · Poeder voor concentraat voor oplossing voor infusie · 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 Polvo Para Concentrado Para Solucion Para Perfusion

1 mg polvo para concentrado para solución para perfusiónSpainMarketedAuthorised 21 Jul 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

Packs

Pack	Code	Status
BESPONSA 1 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION, 1 vial	716783

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.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 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
Strength: 1 mg
Dosage form: polvo para concentrado para solución para perfusión
Route: vía intravenosa
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 21 Jul 2017
Registration: 1171200001
Marketing authorisation holder: Pfizer Europe Ma Eeig
Procedure: EU centralised
Supply: Uso Hospitalario
EU number: EU/1/17/1200