Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800 Puteaux, France
Isturisa 1 mg film-coated tablets.
Isturisa 5 mg film-coated tablets.
Isturisa 10 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Isturisa 1 mg film-coated tablets: Pale yellow, round, biconvex bevelled-edge tablets, marked “Y1” on one side and “NVR” on the other side. Approximate diameter 6.1 mm. Isturisa 5 mg film-coated tablets: Yellow, round, biconvex bevelled-edge tablets, marked “Y2” on one side and “NVR” on the other side. Approximate diameter 7.1 mm. Isturisa 10 mg film-coated tablets: Pale orange brown, round, biconvex bevelled-edge tablets, marked “Y3” on one side and “NVR” on the other side. Approximate diameter 9.1 mm. |
Isturisa 1 mg film-coated tablets: Each film-coated tablet contains osilodrostat phosphate corresponding to 1 mg osilodrostat.
Isturisa 5 mg film-coated tablets: Each film-coated tablet contains osilodrostat phosphate corresponding to 5 mg osilodrostat.
Isturisa 10 mg film-coated tablets: Each film-coated tablet contains osilodrostat phosphate corresponding to 10 mg osilodrostat.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Osilodrostat |
Osilodrostat is a cortisol synthesis inhibitor. It potently inhibits 11β-hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. In Cushing’s disease, the fall in plasma cortisol concentration also stimulates ACTH secretion, via the feedback mechanism which accelerates steroid biosynthesis. |
| List of Excipients |
|---|
|
Tablet core: Cellulose, microcrystalline Film coat: Hypromellose 1 mg tablet: Iron oxide yellow (E172) 5 mg tablet: Iron oxide yellow (E172) 10 mg tablet: Iron oxide yellow (E172) |
Alu/Alu blister of 10 tablets.
Packs containing 60 tablets (6 blisters of 10 tablets).
Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800 Puteaux, France
Isturisa 1 mg film-coated tablets: EU/1/19/1407/001
Isturisa 5 mg film-coated tablets: EU/1/19/1407/002
Isturisa 10 mg film-coated tablets: EU/1/19/1407/003
09 January 2020
| Drug | Countries | |
|---|---|---|
| ISTURISA | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States |
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