Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Idorsia Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Lörrach, Germany
JERAYGO 12.5 mg film-coated tablets.
JERAYGO 25 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). JERAYGO 12.5 mg film-coated tablets: Yellow to orange, round biconvex (6 mm diameter), debossed with “AN” on one side, and plain on the other side. JERAYGO 25 mg film-coated tablets: Pink, round biconvex (6 mm diameter), debossed with “AN” on one side, and “25” on the other side. |
Each film-coated tablet contains 12.5 mg aprocitentan.
Excipients with known effect: Each 12.5 mg film-coated tablet contains 54 mg lactose monohydrate.
Each film-coated tablet contains 25 mg aprocitentan.
Excipients with known effect: Each 25 mg film-coated tablet contains 45.7 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Aprocitentan |
Endothelin (ET)-1, via its receptors (ETA and ETB), mediates a variety of effects such as vasoconstriction, fibrosis, cell proliferation, and inflammation and is upregulated in hypertension. Aprocitentan is a dual ERA that inhibits the binding of ET-1 to ETA and ETB receptors and hence the effects mediated by these receptors. |
| List of Excipients |
|---|
|
Tablet core: Croscarmellose sodium Film coat: Poly(vinyl alcohol) |
JERAYGO 12.5 mg film-coated tablets:
White, opaque, HDPE bottle with child-resistant closure and induction seal liner, containing silica gel desiccant and 30 film-coated tablets.
Perforated unit dose blisters in aluminium cold-form film with desiccant and aluminium push-through lidding foil containing 10 × 1 film-coated tablets.
JERAYGO 25 mg film-coated tablets:
White, opaque, HDPE bottle with child-resistant closure and induction seal liner, containing silica gel desiccant and 30 film-coated tablets.
Perforated unit dose blisters in aluminium cold-form film with desiccant and aluminium push-through lidding foil containing 10 × 1 film-coated tablets.
Not all pack sizes may be marketed
Idorsia Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Lörrach, Germany
EU/1/24/1818/001
EU/1/24/1818/002
EU/1/24/1818/003
EU/1/24/1818/004
Date of first authorisation: 27 June 2024
| Drug | Countries | |
|---|---|---|
| JERAYGO | Austria, Estonia, Lithuania |
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