MHRA-100921-PIP01-23-M04 (update)

Key Facts

Active Substance
Active Substance:
  • AVATROMBOPAG MALEATE
Invented Name
  • Doptelet
  • Doptelet
PIP Number MHRA-100921-PIP01-23-M04 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Powder for oral suspension
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
  • Treatment of Idiopathic Thrombocytopenia Purpura
  • Treatment of Thrombocytopenic Purpura Secondary to Liver Disease
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):AVATROMBOPAG MALEATE.pdf
Published Date 03/10/2024