EMEA-001198-PIP01-11 - paediatric investigation plan

netupitant

Palonosetron

Key facts

• Active Substance:
  • netupitant
  • Palonosetron
• Therapeutic area:
  Other
• Decision number:
  P/0014/2012
• PIP number:
  EMEA-001198-PIP01-11
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Prevention of chemotherapy-induced nausea and vomiting
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Helsinn Birex Pharmaceuticals Limited

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  24/01/2012

Decision

P/0014/2012: EMA decision of 24 January 2012 on the granting of a product specific waiver for netupitant / palonosetron (EMEA-001198-PIP01-11)

AdoptedReference Number: EMA/973120/2011