Crysvita

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burosumab

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Crysvita. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Crysvita.

For practical information about using Crysvita, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 12/03/2018

Authorisation details

Product details
Name
Crysvita
Agency product number
EMEA/H/C/004275
Active substance
Burosumab
International non-proprietary name (INN) or common name
burosumab
Therapeutic area (MeSH)
  • Hypophosphatemia, Familial
  • Hypophosphatemic Rickets, X-Linked Dominant
Anatomical therapeutic chemical (ATC) code
M05BX05
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Kyowa Kirin Limited
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
19/02/2018
Contact address
Galabank Business Park
Galashiels TD1 1QH
United Kingdom

Product information

19/02/2018 Crysvita - EMEA/H/C/004275 -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

DRUGS FOR TREATMENT OF BONE DISEASES

Therapeutic indication

Treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.

Assessment history

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