EMEA-001520-PIP01-13 - paediatric investigation plan

Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA

Key facts

• Active Substance:
  Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA
• Therapeutic area:
  Neurology
• Decision number:
  P/0304/2013
• PIP number:
  EMEA-001520-PIP01-13
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of familial amyloid polyneuropathy
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Alnylam Pharmaceuticals, Inc.

  United States; E-mail: [e-mail]; Tel. [phone]; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/11/2013

Decision

P/0304/2013: EMA decision of 29 November 2013 on the granting of a product specific waiver for synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA (EMEA-001520-PIP01-13)

AdoptedReference Number: EMA/647572/2013