EMEA-000511-PIP01-08-M04 - paediatric investigation plan

propranolol hydrochloride

Key facts

• Invented name:
  • Hemangiol
  • Hemangiol
• Active substance:
  propranolol hydrochloride
• Therapeutic area:
  Dermatology
• Decision number:
  P/0004/2013
• PIP number:
  EMEA-000511-PIP01-08-M04
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of haemangioma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/01/2013
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-000511-PIP01-08-M04
• Compliance opinion date:
  14/02/2013
• Compliance outcome:
  Positive

Decision

P/0004/2013: EMA decision of 21 January 2013 on the acceptance of a modification of an agreed paediatric investigation plan for propranolol hydrochloride (EMEA-000511-PIP01-08-M04)

Adopted Reference Number: EMA/795938/2012