MHRA-100273-PIP01-21

Key Facts

Active Substance
Active Substance:
  • 5-Ethoxy-1-(6-(3-methyl-2-((5-methyl-2-(tetrahydro-2Hpyran- 4-yl)-1,2,3,4-tetrahydroisoquinolin-6- yl)methoxy)phenyl)pyridin-2-yl)-1H-pyrazole-4- carboxylic acid
Invented Name
Not yet available
PIP Number MHRA-100273-PIP01-21
Pharmaceutical form(s)
  • Modified-release film-coated tablet
  • Modified-release granules
  • Age-appropriate formulation
Therapeutic area
Therapeutic area:
  • Uro-Nephrology
Conditions / Indications
Conditions / Indications:
  • Treatment of Chronic Kidney Disease
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):5-Ethoxy-1-(6-(3-methyl-2-((5-methyl-2-(tetrahydro-2Hpyran- 4-yl)-1,2,3,4-tetrahydroisoquinolin-6- yl)methoxy)phenyl)pyridin-2-yl)-1H-pyrazole-4- carboxylic acid.pdf
Published Date 07/12/2022