POMALIDOMIDE JN pomalidomide 1 mg hard gelatin capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pomalidomide, Quantity: 1 mg

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: sodium stearylfumarate; mannitol; pregelatinised starch; croscarmellose sodium; titanium dioxide; indigo carmine; purified water; iron oxide yellow; Gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; ethanol absolute; ammonia

Administration route:

Oral

Units in package:

21 capsules, 14 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Pomalidomide, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide.,Pomalidomide, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Product summary:

Visual Identification: Size 4 hard gelatin capsules with dark blue cap and a yellow body printed with 'NAT' in white ink on the cap and '1 mg' in black ink on the body of the capsules.; 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

Authorization date:

2021-05-18