Medicines Substances Companies Statistics

A free, open platform for EU medicines data, based on official EMA data.

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Medicines
Substances
Companies

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EMA

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Vanflyta

Refused

Human

Details

EMA number	EMEA/H/C/004468
ATC code	L01XE
Authorisation	-
Revision	-

Therapeutic indication

Treatment of acute myeloid leukaemia.

MeSH: Leukemia, Myeloid, Acute

Group: Antineoplastic agents

Active substances

quizartinib dihydrochloride

Marketing Authorisation Holder

Daiichi Sankyo Europe GmbH

Timeline

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Status changed: Authorised → Refused

31 Jul 2026

status_changedregulatory

Vanflyta authorised

6 Nov 2023

authorisedregulatory

Vanflyta | uMedical