Isturisa

RSS

osilodrostat

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

Overview

Isturisa is a medicine used to treat adults with Cushing’s syndrome, a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys.

Cushing’s syndrome is rare, and Isturisa was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 October 2014.

Isturisa contains the active substance osilodrostat.

This EPAR was last updated on 16/06/2020

Authorisation details

Product details
Name
Isturisa
Agency product number
EMEA/H/C/004821
Active substance
Osilodrostat phosphate
International non-proprietary name (INN) or common name
osilodrostat
Therapeutic area (MeSH)
Cushing Syndrome
Anatomical therapeutic chemical (ATC) code
H02CA02
Additional monitoringAdditional 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.

OrphanOrphan

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
Recordati Rare Diseases
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
09/01/2020
Contact address

Immeuble le Wilson
70, avenue du Général de Gaulle
92800 Puteaux
France

Product information

01/04/2020 Isturisa - EMEA/H/C/004821 - T/0001

Contents

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

Corticosteroids for systemic use

Therapeutic indication

Isturisa is indicated for the treatment of endogenous Cushing’s syndrome in adults.

Assessment history

How useful was this page?

Add your rating
Average
2 ratings