EMEA-001099-PIP02-11-M01 - paediatric investigation plan

MAGE-A3 recombinant protein

Key facts

• Active Substance:
  MAGE-A3 recombinant protein
• Therapeutic area:
  Oncology
• Decision number:
  P/0294/2014
• PIP number:
  EMEA-001099-PIP02-11-M01
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  GlaxoSmithKline Biologicals S.A. (Belgium)

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/10/2014

Decision

P/0294/2014: EMA decision of 30 October 2014on the acceptance of a modification of an agreed paediatric investigation plan for MAGE-A3 recombinant protein (EMEA-001099-PIP02-11-M01)

AdoptedReference Number: EMA/590079/2014