EMEA-001945-PIP01-16-M03 - paediatric investigation plan

Avalglucosidase alfa

Key facts

• Active Substance:
  Avalglucosidase alfa
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0360/2021
• PIP number:
  EMEA-001945-PIP01-16-M03
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Pompe disease
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Sanofi B.V.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2021

Decision

P/0360/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for avalglucosidase alfa (EMEA-001945-PIP01-16-M03)

AdoptedReference Number: EMA/418754/2021