MHRA-100043-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • zilucoplan
Invented Name
  • Zilbrysq
  • Zilqivik
PIP Number MHRA-100043-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Solution for injection in pre-filled syringe
  • Age appropriate dosage form for parenteral use.
Therapeutic area
  • Neurology
  • Other: Complement inhibitor for treatment of the autoimmune disease myasthenia gravis
Conditions / Indications
Conditions / Indications:
  • Treatment of myasthenia gravis
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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 19/12/2023