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
• Contact for public enquiries:

  River Vision Development Corporation

  United States; E-mail: [e-mail] ; Tel.: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/12/2016

Decision

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

AdoptedReference Number: EMA/741998/2016