EMEA-003500-PIP01-23 - paediatric investigation plan

elinzanetant

Key facts

• Active Substance:
  elinzanetant
• Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-Metabolism
  • Neurology
• Decision number:
  P/0506/2023
• PIP number:
  EMEA-003500-PIP01-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of vasomotor symptoms caused by endocrine therapy related to breast cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/12/2023

Decision

P/0506/2023: EMA decision of of 29 December 2023 on the granting of a product specific waiver for elinzanetant (EMEA-003500-PIP01-23)

AdoptedReference Number: EMA/528360/2023