Key facts

Invented name
Doptelet
Active Substance
avatrombopag maleate
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0010/2023
PIP number
EMEA-001136-PIP01-11-M02
Pharmaceutical form(s)
  • Film-coated tablet
  • Powder for oral suspension
Condition(s) / indication(s)
  • Treatment of Idiopathic Thrombocytopenia Purpura (ITP)
  • Treatment of Thrombocytopenic Purpura Secondary to Liver Disease
Route(s) of administration
Oral use
Contact for public enquiries

Swedish Orphan Biovitrum AB (publ)

Tel. +46 8697 2000
E-mail: medical.info@sobi.com

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

Decision

P/0010/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for avatrombopag (maleate) (Doptelet), (EMEA-001136-PIP01-11-M02)

How useful do you find this page?