EMEA-000822-PIP01-09-M01 - paediatric investigation plan

bucelipase alfa

Key facts

• Active substance:
  bucelipase alfa
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0092/2013
• PIP number:
  EMEA-000822-PIP01-09-M01
• Pharmaceutical form(s):
  Powder for oral solution
• Condition(s) / indication(s):
  Prevention of growth retardation due to lack of bile-salt-stimulated lipase in enteral nutrition
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/04/2013
• Compliance check done:
  No

Decision

P/0092/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for bucelipase alfa (EMEA-000822-PIP01-09-M01)

Adopted Reference Number: EMA/179906/2013