EMEA-001365-PIP01-12 - paediatric investigation plan

anamorelin hydrochloride

Key facts

• Active Substance:
  anamorelin hydrochloride
• Therapeutic area:
  Other
• Decision number:
  P/0134/2014
• PIP number:
  EMEA-001365-PIP01-12
• Pharmaceutical form(s):
  • Tablet
  • Oral liquid
• Condition(s) / indication(s):
  Treatment of cancer related cachexia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Helsinn Therapeutics (U.S.) Inc.

  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:
  10/06/2014

Decision

P/0134/2014: EMA decision of 10 June 2014 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for anamorelin (hydrochloride) (EMEA-001365-PIP01-12)

AdoptedReference Number: EMA/275459/2014