EMEA-001476-PIP01-13-M01

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Overview

Product details for Kuvan
Invented nameKuvan
Active substance

Sapropterin dihydrochloride

Decision numberP/0249/2016
PIP numberEMEA-001476-PIP01-13-M01
Pharmaceutical form(s)Soluble tablet; Powder for oral solution
Condition(s)/indication(s)

Treatment of hyperphenylalaninemia

Route(s) of administrationOral use
PIP applicant

BioMarin International Limited
United Kingdom
Tel. +44 2074200800
Fax +44 2074200829
E-mail: biomarin-europe@bmrn.com

Decision typePM: decision on the application for modification of an agreed PIP

Decision