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

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

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

Tilgængelig fra:

Southern Cross Pharma Pty Ltd

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

28 tablets

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Treatment of major depression in adults including prevention of relapse.

Produkt oversigt:

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

Autorisation status:

Registered

Autorisation dato:

2020-06-26