EMEA-002064-PIP01-16-M01

Key facts

Active substance
Gilteritinib (as fumarate)
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0194/2019
PIP number
EMEA-002064-PIP01-16-M01
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral dosage form
Condition(s) / indication(s)
Treatment of acute myeloid leukaemia
Route(s) of administration
Oral use
Contact for public enquiries
Astellas Pharma Europe B.V.

Tel. +31 7154 55878
E-mail: contact@nl.astellas.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

How useful was this page?

Add your rating
Average
1 rating
3 ratings