EMEA-001374-PIP01-12 - paediatric investigation plan

exon 53 specific phosphorothioate oligonucleotide

Key facts

• Active substance:
  exon 53 specific phosphorothioate oligonucleotide
• Therapeutic area:
  Other
• Decision number:
  P/0247/2013
• PIP number:
  EMEA-001374-PIP01-12
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of Duchenne muscular dystrophy
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  04/10/2013
• Compliance check done:
  Nej

Decision

P/0247/2013: EMA decision of 4 October 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for exon 53 specific phosphorothioate oligonucleotide (EMEA-001374-PIP01-12)

Reference Number: EMA/592589/2013