EMEA-001476-PIP01-13-M01

Key facts

Invented name
Kuvan
Active substance
Sapropterin dihydrochloride
Therapeutic area
Endocrinology, -gynacology-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
United Kingdom
Tel. +44 2074200800
Fax +44 2074200829
E-mail: biomarin-europe@bmrn.com
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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