MHRA-100432-PIP01-22

Key Facts

PIPS 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

PIPS Decision Documents
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