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
Yes
Compliance Check Decision Date
Compliance opinion date
14/01/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100921-PIP01-23-M04-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):AVATROMBOPAG MALEATE.pdf
Published Date 16/07/2026