ATOMOXETINE GENPAR atomoxetine (as hydrochloride) 5 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atomoxetine hydrochloride, Quantity: 5.715 mg (Equivalent: atomoxetine, Qty 5 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Atomoxetine hydrochloride

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; Gelatin; titanium dioxide; iron oxide yellow; pregelatinised maize starch; croscarmellose sodium; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

56 capsules, 7 capsules, 14 capsules, 28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ATOMOXETINE GENPAR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as defined by DSM-IV criteria in children 6 years of age and older, adolescents and adults.

Product summary:

Visual Identification: Yellow capsule with the printed markings 5 mg on the capsule body; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-01-22