EMEA-003294-PIP01-22 - paediatric investigation plan

Eplontersen

Key facts

• Active Substance:
  Eplontersen
• Therapeutic area:
  Neurology
• Decision number:
  P/0534/2022
• PIP number:
  EMEA-003294-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of transthyretin amyloidosis (ATTR)
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  AstraZeneca AB

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/12/2022

Decision

P/0534/2022 : EMA decision of 30 December 2022 on the granting of a product specific waiver for eplontersen (EMEA-003294-PIP01-22)

AdoptedReference Number: EMA/930232/2022