Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
VANFLYTA 17.7 mg film-coated tablets.
VANFLYTA 26.5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). VANFLYTA 17.7 mg film-coated tablets: White, round-shaped film-coated tablets, 8.9 mm in diameter and debossed with ‘DSC 511’ on one side. VANFLYTA 26.5 mg film-coated tablets: Yellow, round-shaped film-coated tablets, 10.2 mm in diameter and debossed with ‘DSC 512’ on one side. |
VANFLYTA 17.7 mg film-coated tablets: Each film-coated tablet contains 17.7 mg quizartinib (as dihydrochloride).
VANFLYTA 26.5 mg film-coated tablets: Each film-coated tablet contains 26.5 mg quizartinib (as dihydrochloride).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Quizartinib |
Quizartinib is an inhibitor of the receptor tyrosine kinase FLT3. Quizartinib and its major metabolite AC886 competitively bind to the adenosine triphosphate (ATP) binding pocket of FLT3 with high affinity. Quizartinib and AC886 inhibit FLT3 kinase activity, preventing autophosphorylation of the receptor, thereby inhibiting further downstream FLT3 receptor signalling and blocking FLT3-ITDdependent cell proliferation. |
| List of Excipients |
|---|
VANFLYTA 17.7 mg film-coated tabletsTablet core: Hydroxypropylbetadex Film-coating: Hypromellose (E464) VANFLYTA 26.5 mg film-coated tabletsTablet core: Hydroxypropylbetadex Film-coating: Hypromellose (E464) |
Aluminium/aluminium perforated unit dose blisters.
VANFLYTA 17.7 mg film-coated tablets: Cartons containing 14 × 1 or 28 × 1 film-coated tablets.
VANFLYTA 26.5 mg film-coated tablets: Cartons containing 14 × 1, 28 × 1 or 56 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
EU/1/23/1768/001-005
| Drug | Countries | |
|---|---|---|
| VANFLYTA | Austria, Estonia, France, Croatia, Ireland, Italy, Japan, Lithuania, United States |
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