FGI-AGOMELATINE agomelatine (as agomelatine-citric acid) 25 mg 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:

Helix Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depressive disorder (MDD) 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: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered