EMEA-001973-PIP02-23 - paediatric investigation plan

teprotumumab

Key facts

• Active substance:
  teprotumumab
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0381/2023
• PIP number:
  EMEA-001973-PIP02-23
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of thyroid eye disease
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/09/2023
• Compliance check done:
  No

Decision

P/0381/2023 : EMA decision of 7 September 2023 on the granting of a product specific waiver for teprotumumab, (EMEA-001973-PIP02-23)

Reference Number: EMA/389821/2023