EMEA-001308-PIP01-12-M02 - paediatric investigation plan

paclitaxel

Key facts

• Invented name:
  • Abraxane
  • Abraxane
• Active Substance:
  paclitaxel
• Therapeutic area:
  Oncology
• Decision number:
  P/0257/2018
• PIP number:
  EMEA-001308-PIP01-12-M02
• Pharmaceutical form(s):
  Powder for suspension for infusion
• Condition(s) / indication(s):
  Treatment of solid malignant tumours
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Celgene Europe Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/08/2018
• Compliance procedure number:
  EMEA-C-001308-PIP01-12-M02
• Compliance opinion date:
  21/09/2018
• Compliance outcome:
  Positive

Decision

P/0257/2018: EMA decision of 14 August 2018 on the acceptance of a modification of an agreed paediatric investigation plan for paclitaxel Abraxane), (EMEA-001308-PIP01-12-M02)

Reference Number: EMA/521807/2018