MHRA-102261-PIP01-25

Key Facts

Active Substance
Active Substance:
  • Human IgG1 kappa monoclonal antibody against TREM2
Invented Name
Not yet available
PIP Number MHRA-102261-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of Amyotrophic lateral sclerosis
Route(s) of administration
Route(s) of administration:
  • intravenous
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(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):Human IgG1 kappa monoclonal antibody against TREM2.pdf
Published Date 03/07/2026