EMEA-001331-PIP01-12-M02 - paediatric investigation plan

sebelipase alfa

Key facts

• Active Substance:
  sebelipase alfa
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0173/2015
• PIP number:
  EMEA-001331-PIP01-12-M02
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of lysosomal acid-lipase deficiency
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Alexion Europe SAS

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/08/2015
• Compliance procedure number:
  EMEA-C-001331-PIP01-12-M02
• Compliance opinion date:
  01/03/2019
• Compliance outcome:
  Positive

Decision

P/0173/2015: EMA decision of 7 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for sebelipase alfa (EMEA-001331-PIP01-12-M02)

AdoptedReference Number: EMA/434301/2015