Gemtuzumab ozogamicin

Mylotarg 5 MG Polvo Para Concentrado Para Solucion Para Perfusion

5 mg polvo para concentrado y solución para solución para perfusionSpainMarketedAuthorised 24 May 2018

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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.

MylotargEuropean UnionAuthorised

MylotargCanada · 4.5 MG / VIAL · Powder For Solution · Pfizer Canada UlcSame brand
MylotargEuropean Union · Pfizer Europe MA EEIGSame brand
MylotargEuropean Union · Wyeth Europa LtdSame brand
MylotargCroatiaSame brand
MylotargItaly · Polvere per concentrato per soluzione per infusione · Pfizer Europe Ma EeigSame brand
Mylotarg 5 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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Gemtuzumab ozogamicin

Mylotarg 5 MG Polvo Para Concentrado Para Solucion Para Perfusion

5 mg polvo para concentrado y solución para solución para perfusionSpainMarketedAuthorised 24 May 2018

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.

MylotargEuropean 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

MylotargNew Zealand · Inj 5 mg vial

Mylotarg Powder for Concentrate for Solution for Infusion 5MG/VialSingapore · 5.0 mg/vial · powder, for solution · Pfizer Private Limited

MylotargUnited States · 4.5MG · vial · Wyeth Pharms INC

Packs

Pack	Code	Status
MYLOTARG 5 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION, 1 vial	721601

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: Gemtuzumab ozogamicin
Strength: 5 mg
Dosage form: polvo para concentrado y solución para solución para perfusion
Route: vía intravenosa
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 24 May 2018
Registration: 1181277001
Marketing authorisation holder: Pfizer Europe Ma Eeig
Procedure: EU centralised
Supply: Uso Hospitalario
EU number: EU/1/18/1277