EMEA-000987-PIP01-10-M04 - paediatric investigation plan

asfotase alfa

Key facts

• Invented name:
  Strensiq
• Active Substance:
  asfotase alfa
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0176/2019
• PIP number:
  EMEA-000987-PIP01-10-M04
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hypophosphatasia
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Alexion Europe SAS

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/05/2019
• Compliance procedure number:
  EMEA-C-000987-PIP01-10-M04
• Compliance opinion date:
  18/10/2019
• Compliance outcome:
  Positive

Decision

P/0176/2019: EMA decision of 15 May 2019 on the acceptance of a modification of an agreed paediatric investigation plan for asfotase alfa (Strensiq), (EMEA-000987-PIP01-10-M04)

AdoptedReference Number: EMA/241894/2019