EMEA-001973-PIP01-16 - paediatric investigation plan

teprotumumab

Key facts

• Active substance:
  teprotumumab
• Decision number:
  P/0345/2016
• PIP number:
  EMEA-001973-PIP01-16
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of active thyroid eye disease
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/12/2016
• Compliance check done:
  Nie

Decision

P/0345/2016: EMA decision of 2 December 2016 on the granting of a product specific waiver for teprotumumab (EMEA-001973-PIP01-16)

Adopted Reference Number: EMA/741998/2016