EMEA-001476-PIP01-13-M01 - paediatric investigation plan

Sapropterin dihydrochloride

Key facts

• Invented name:
  • Kuvan
  • Kuvan
• Active Substance:
  Sapropterin dihydrochloride
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0249/2016
• PIP number:
  EMEA-001476-PIP01-13-M01
• Pharmaceutical form(s):
  • Soluble tablet
  • Powder for oral solution
• Condition(s) / indication(s):
  Treatment of hyperphenylalaninemia
• Route(s) of administration:
  Oral 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:
  09/09/2016
• Compliance procedure number:
  EMEA-C-001476-PIP01-13
• Compliance opinion date:
  10/10/2014
• Compliance outcome:
  Positive

Decision

P/0249/2016: EMA decision of 9 September 2016 on the acceptance of a modification of an agreed paediatric investigation plan for sapropterin dihydrochloride (Kuvan), (EMEA-001476-PIP01-13-M01)

Reference Number: EMA/585771/2016