AGOMELATINE ANS agomelatine (as agomelatine-citric acid) 25 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

agomelatine-citric acid, Quantity: 44.739 mg (Equivalent: agomelatine, Qty 25 mg)

Available from:

Southern Cross Pharma Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; crospovidone; mannitol; povidone; sodium stearylfumarate; silicified microcrystalline cellulose; magnesium stearate; stearic acid; hypromellose; macrogol 6000; titanium dioxide; purified talc; iron oxide yellow

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression in adults including prevention of relapse.

Product summary:

Visual Identification: yellow, oblong biconvex film coated tablet; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-06-26