EMEA-002365-PIP01-18 - paediatric investigation plan

Liposomal vinorelbine (tartrate)

Key facts

• Active Substance:
  Liposomal vinorelbine (tartrate)
• Therapeutic area:
  Oncology
• Decision number:
  P/0155/2019
• PIP number:
  EMEA-002365-PIP01-18
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of rhabdomyosarcoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  17/04/2019

Decision

P/0155/2019: EMA decision of 17 April 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for liposomal vinorelbine (tartrate) (EMEA-002365-PIP01-18)

AdoptedReference Number: EMA/215265/2019