Vanflyta

Unknown🇪🇺 European Union

EMA Page

Authorised Date: N/A
Approval ID: 998aa94b615d50b1
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

The European Medicines Agency has recommended the refusal of the marketing authorisation for Vanflyta, a medicine intended for the treatment of adults with acute myeloid leukaemia (AML) (a cancer of the white blood cells). The Agency issued its opinion on 17 October 2019\. The company that applied for authorisation, Daiichi Sankyo Europe GmbH, may ask for re\-examination of the opinion within 15 days of receiving the opinion.

Therapeutic & Classification

Therapeutic Indication

N/A

Therapeutic Area (MeSH)

Leukemia, Myeloid, Acute

ATC Code

L01XE

ATC Item

N/A

Pharmacotherapeutic Group

Antineoplastic agents

Active Substances

Active Substance (Summary)

quizartinib dihydrochloride

INN / Common Names

quizartinib

Active Substance Details

Active substance details are not yet available.

Quick Info

Approval ID998aa94b615d50b1

Product NumberN/A

StatusAuthorised

Authorised DateN/A

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Vanflyta

Medicine Name

Vanflyta

Aliases

N/A

Regulatory Flags

Orphan medicineUnknown

Generic medicineUnknown

BiosimilarUnknown

Conditional approvalUnknown

Exceptional circumstancesUnknown

Accelerated assessmentUnknown

Additional monitoringUnknown

Advanced therapyUnknown

Source Links

EMA Source

No risk management plan link.

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