EMEA-000174-PIP01-07-M03 - paediatric investigation plan

Plerixafor

Key facts

• Invented name:
  • Mozobil
  • Mozobil
• Active substance:
  Plerixafor
• Therapeutic area:
  Oncology
• Decision number:
  P/0253/2013
• PIP number:
  EMEA-000174-PIP01-07-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Myelosuppression caused by chemotherapy to treat malignant disorders, which requires an autologous haematopoietic stem cell transplant
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/10/2013
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000174-PIP01-07-M03
• Compliance opinion date:
  26/01/2018
• Compliance outcome:
  Positive

Decision

P/0253/2013: EMA decision of 29 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for plerixafor (Mozobil) (EMEA-000174-PIP01-07-M03)

Adopted Reference Number: EMA/599869/2013