EMEA-000646-PIP01-09-M01 - paediatric investigation plan

peginesatide

Key facts

• Active substance:
  peginesatide
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0251/2012
• PIP number:
  EMEA-000646-PIP01-09-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of symptomatic anaemia associated with chronic kidney disease
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/10/2012
• Compliance check done:
  No

Decision

P/0251/2012: EMA decision of 24 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for peginesatide (EMEA-000646-PIP01-09-M01)

Adopted Reference Number: EMA/666263/2012