MHRA-100532-PIP01-22-M02 (update)

Key Facts

PIPS Key Facts
Active Substance	Active Substance: BUROSUMAB
Invented Name	Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita
PIP Number	MHRA-100532-PIP01-22-M02 (update)
Pharmaceutical form(s)	Pharmaceutical form(s): Solution for injection
Therapeutic area	Therapeutic area: Other: musculoskeletal disorder; osteology
Conditions / Indications	Conditions / Indications: Treatment of X-linked Hypophosphataemia
Route(s) of administration	Route(s) of administration: Subcutaneous use
PIP applicant	Kyowa Kirin Holdings BV Country Netherlands Tel 01896664000 Email regulatorygroup@kyowakirin.com
Decision Type	Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check	Compliance Check Yes
Compliance Check Decision Date	Compliance opinion date 30/09/2024
Compliance Check Procedure Number	Compliance procedure number MHRA-100532-PIP01-22-M02-C1

Decision Document

PIPS Decision Documents
Decision Document	Decision Document on a Paediatric Investigation Plan (PIP):BUROSUMAB.pdf
Published Date	01/05/2026