Epoetin theta - paediatric investigation plan

epoetin theta

Key facts

• Active substance:
  epoetin theta
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/57/2008
• PIP number:
  Epoetin theta
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of anaemia
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  20/07/2008
• Compliance check done:
  No

Decision

P/57/2008: European medicines agency decision of 20 July 2008 on the application for product specific waiver for Epoetin theta (EMEA-000219-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parli...

Adopted Reference Number: EMEA/357430/2008