EMEA-001836-PIP01-15 - paediatric investigation plan

Revusiran

Key facts

• Active Substance:
  Revusiran
• Therapeutic area:
  Neurology
• Decision number:
  P/0031/2016
• PIP number:
  EMEA-001836-PIP01-15
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of transthyretin-related amyloidosis (ATTR amyloidosis)
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Alnylam Pharmaceuticals, Inc.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/01/2016

Decision

P/0031/2016: EMA decision of 29 January 2016 on the granting of a product specific waiver for revusiran (EMEA-001836-PIP01-15)

AdoptedReference Number: EMA/13230/2016