SOHONOS palovarotene 10 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

palovarotene, Quantity: 10 mg

Available from:

Ipsen Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: povidone; magnesium stearate; lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; croscarmellose sodium; titanium dioxide; potable water; Gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; Shellac; ethanol absolute; iron oxide black; ammonia; potassium hydroxide

Administration route:

Oral

Units in package:

28 hard capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SOHONOS is indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with fibrodysplasia ossificans progressiva (FOP).

Product summary:

Visual Identification: Size 0 hard gelatin capsules with opaque white body and cap, imprinted with "PVO 10" on each side of the capsule body in black ink; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered