EMEA-002981-PIP01-21 - paediatric investigation plan

2'-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide targeting CD49d RNA (ATL1102)

Key facts

• Active Substance:
  2'-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide targeting CD49d RNA (ATL1102)
• Therapeutic area:
  Other
• Decision number:
  P/0504/2021
• PIP number:
  EMEA-002981-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Duchenne muscular dystrophy
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Percheron Therapeutics Limited; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  03/12/2021

Decision

P/0504/2021 - EMA decision of of 3 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver ... (EMEA-002981-PIP01-21)

AdoptedReference Number: EMA/624102/2021