MHRA-100060-PIP01-21

Key Facts

Active Substance
Active Substance:
  • 2'-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide targeting CD49d RNA
Invented Name
Not yet available
PIP Number MHRA-100060-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Other: Neuromuscular
Conditions / Indications
Conditions / Indications:
  • Treatment of Duchenne muscular dystrophy
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
  • Antisense Therapeutics Limited, Australia
  • Country Australia
  • Tel +61398278999
  • Email info@antisense.com.au
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):2'-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide targeting CD49d RNA.pdf
Published Date 17/03/2022