EMEA-003138-PIP01-21 - paediatric investigation plan

Tarlatamab

Key facts

• Active Substance:
  Tarlatamab
• Therapeutic area:
  Oncology
• Decision number:
  P/0090/2022
• PIP number:
  EMEA-003138-PIP01-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  • Treatment of prostate malignant neoplasms
  • Treatment of small cell lung cancer
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Amgen Europe BV

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/03/2022

Decision

P/0090/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for tarlatamab (EMEA-003138-PIP01-21)

AdoptedReference Number: EMA/101043/2022