Gemtuzumab ozogamicin

Mylotarg

Polvere per concentrato per soluzione per infusioneItalyAuthorised

In other countries

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

MylotargCanada · 4.5 MG / VIAL · Powder For Solution · Pfizer Canada UlcSame brand
Mylotarg 5 MG Polvo Para Concentrado Para Solucion Para PerfusionSpain · 5 mg · polvo para concentrado y solución para solución para perfusion · Pfizer Europe Ma EeigSame brand
MylotargEuropean Union · Pfizer Europe MA EEIGSame brand
MylotargEuropean Union · Wyeth Europa LtdSame brand
MylotargCroatiaSame brand
Mylotarg 5 mg, poeder voor concentraat voor oplossing voor infusieNetherlands · Poeder voor concentraat voor oplossing voor infusie · Pfizer Europe MA EEIGSame brand
MylotargNew Zealand · Inj 5 mg vial

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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

Polvere per concentrato per soluzione per infusioneItalyAuthorised

Product informationAsk Osler about it

In other countries

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

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

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
5 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO	046485013	Autorizzata

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.

Agenzia Italiana del Farmaco (AIFA), Italy

Agenzia Italiana del Farmaco (AIFA); https://drive.aifa.gov.it/farmaci/confezioni_fornitura.csv; HTTP Last-Modified Mon, 12 Oct 2026 23:02:44 GMT; acquired 2026-10-13T17:21:16.224007+00:00; native fields retained, source identifier and role projections are adaptations.

Licence: CC BY 4.0; AIFA published open-data catalog · Added 13 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
Dosage form: Polvere per concentrato per soluzione per infusione
Register: Italy (AIFA)
Status: Authorised
Status in the register: Autorizzata
Registration: AIC 046485
Marketing authorisation holder: Pfizer Europe Ma Eeig
ATC code: L01FX02
Group: Antineoplastic and immunomodulating agents
Procedure: Procedura Centralizzata
Supply: Medicinali soggetti a prescrizione medica limitativa, utilizzabili esclusivamente in ambiente ospedaliero o in una struttura ad esso assimilabile