EMEA-000275-PIP01-08 - paediatric investigation plan

rolofylline

Key facts

• Active substance:
  rolofylline
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/87/2009
• PIP number:
  EMEA-000275-PIP01-08
• Pharmaceutical form(s):
  Emulsion for injection
• Condition(s) / indication(s):
  Heart Failure
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  18/05/2009
• Compliance check done:
  No

Decision

P/87/2009: European medicines agency decision of 18 May 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral for rolofylline (EMEA-000275-PIP01-08) in accordance with Regulation (EC)...

Adopted Reference Number: EMEA/288303/2009