MHRA-100885-PIP01-23

Key Facts

Active Substance
Active Substance:
  • Iptacopan
Invented Name
Not available at present; Product code: LNP023
PIP Number MHRA-100885-PIP01-23
Pharmaceutical form(s)
  • Capsule, hard
  • Age appropriate formulation
Therapeutic area
  • Haematology-Hemostaseology
  • Other: Complement-driven renal disease
Conditions / Indications
Conditions / Indications:
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
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
Yes
Compliance Check Decision Date
Compliance opinion date
10/11/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100885-PIP01-23-C2

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Iptacopan.pdf
Published Date 19/12/2023