MHRA-100363-PIP01-21

Key Facts

Active Substance
Active Substance:
  • Repagermanium
Invented Name
Not yet available
PIP Number MHRA-100363-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsule, hard
Therapeutic area
Therapeutic area:
  • Uro-Nephrology
Conditions / Indications
Conditions / Indications:
  • Treatment of focal segmental glomerulosclerosis (FSGS)
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Dimerix Bioscience Pty Ltd
  • Country Australia
  • Tel +611300813321
  • Email info@dimerix.com
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):Repagermanium.pdf
Published Date 24/06/2024