EMEA-000172-PIP01-07-M03 - paediatric investigation plan

Methoxy polyethylene glycol-epoetin beta

Key facts

• Invented name:
  Mircera
• Active Substance:
  Methoxy polyethylene glycol-epoetin beta
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0317/2017
• PIP number:
  EMEA-000172-PIP01-07-M03
• 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
• Contact for public enquiries:

  Roche Registration Limited

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

• Decision type:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  31/10/2017
• Compliance procedure number:
  EMEA-C-000172-PIP01-07-M03
• Compliance opinion date:
  20/05/2022
• Compliance outcome:
  Positive

Decision

P/0317/2017: EMA decision of 31 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for methoxy polyethylene glycol - epoetin beta (Mircera) (EMEA-000172-PIP01-07-M03)

Reference Number: EMA/662067/2017