Isturisa
osilodrostat
Table of contents
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.
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List item
Isturisa : EPAR - Medicine overview (PDF/115.96 KB)
First published: 18/02/2020
EMA/644850/2019 -
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List item
Isturisa : EPAR - Risk-management-plan summary (PDF/99.84 KB)
First published: 18/02/2020
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 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. |
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 | |
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Marketing-authorisation holder |
Recordati Rare Diseases
|
Revision |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
09/01/2020
|
Contact address |
Product information
01/04/2020 Isturisa - EMEA/H/C/004821 - T/0001
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
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Pharmacotherapeutic group
Corticosteroids for systemic use
Therapeutic indication
Isturisa is indicated for the treatment of endogenous Cushing’s syndrome in adults.