EMEA-001659-PIP01-15-M06

Table of contents

Key facts

Invented name
Crysvita
Active substance
Burosumab
Therapeutic area
Other
Decision number
P/0411/2022
PIP number
EMEA-001659-PIP01-15-M06
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of X-linked hypophosphataemia
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Kyowa Kirin Holdings B.V.

Tel. +44 (0)1896 664000
E-mail: regulatorygroup@kyowakirin.com

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

Decision

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