MHRA-100432-PIP01-22

Key Facts

Active Substance
Active Substance:
  • 2-Amino-N-(4-hydroxybicyclo[2.2.2]octan-1-yl)-5-(4-((1R,5S)-3- (tetrahydro-2H-pyran-4-yl)-3-azabicyclo[3.1.0]hexan-1- yl)phenyl)nicotinamide fumarate dihydrate
Invented Name
Not yet available
PIP Number MHRA-100432-PIP01-22
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate solid dosage form
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of fibrodysplasia ossificans progressiva
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
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):2-Amino-N-(4-hydroxybicyclo[2.2.2]octan-1-yl)-5-(4-((1R,5S)-3-(tetrahydro-2H-pyran-4-yl)-3-azabicyclo[3.1.0]hexan-1-yl)phenyl)nicotinamide fumarate dihydrate.pdf
Published Date 07/12/2022