MHRA-100043-PIP01-21

Key Facts

Active Substance
Active Substance:
  • zilucoplan
Invented Name
  • Zilbrysq
  • Zilqivik
PIP Number MHRA-100043-PIP01-21
Pharmaceutical form(s)
  • Solution for injection
  • Age appropriate dosage form for parenteral use.
Therapeutic area
  • Neurology
  • Other: Neurodegenerative disorder, auto-immune disease/dysfunction
Conditions / Indications
Conditions / Indications:
  • Treatment of myasthenia gravis
Route(s) of administration
Route(s) of administration:
  • Subcutaneous 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):zilucoplan.pdf
Published Date 17/03/2022