MHRA-100299-PIP01-21

Key Facts

Active Substance
Active Substance:
  • Humanized monoclonal IgG1-based antibody
Invented Name
Not available at present
PIP Number MHRA-100299-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of spinal muscular atrophy
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
  • ROCHE PRODUCTS LIMITED
  • Country United Kingdom
  • Tel +447901266003
  • Email uk.dra@roche.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):Humanized monoclonal IgG1-based antibody .pdf
Published Date 19/12/2023