NORTIM agomelatine 25 mg film-coated tablet blister pack.

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

agomelatine, Quantity: 25 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

INN (International Name):

Agomelatine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; povidone; stearic acid; colloidal anhydrous silica; sodium starch glycollate type A; maize starch; lactose monohydrate; propylene glycol; butan-1-ol; ethanol; isopropyl alcohol; Shellac; strong ammonia solution; indigo carmine aluminium lake; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; glycerol

Administration route:

Oral

Units in package:

28 tablets (commercial pack), 56 tablets, 7 tablets (medical sample)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment in adults of: - of major depression (MDD) including prevention of relapse - generalised anxiety disorder (GAD)

Product summary:

Visual Identification: Orange-yellow, oblong film-coated tablet with blue imprint of Servier logo on one face; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-11-15