EMEA-001840-PIP01-15 - paediatric investigation plan

telotristat etiprate

Key facts

• Active substance:
  telotristat etiprate
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0318/2015
• PIP number:
  EMEA-001840-PIP01-15
• Pharmaceutical form(s):
  Coated tablet
• Condition(s) / indication(s):
  Treatment of carcinoid syndrome
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/12/2015
• Compliance check done:
  Не

Decision

P/0318/2015: EMA decision of 21 December 2015 on the granting of a product-specific waiver for telotristat etiprate (EMEA-001840-PIP01-15)

Adopted Reference Number: EMA/759754/2015