EMEA-001951-PIP01-16-M02 - paediatric investigation plan

Pegvaliase

Key facts

• Invented name:
  Palynziq
• Active Substance:
  Pegvaliase
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0089/2022
• PIP number:
  EMEA-001951-PIP01-16-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hyperphenylalaninaemia
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  BioMarin International Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/03/2022

Decision

P/0089/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for pegvaliase (Palynziq), (EMEA-001951-PIP01-16-M02)

AdoptedReference Number: EMA/100063/2022