APOTEX-Amisulpride 200 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amisulpride, Quantity: 200 mg

Available from:

GM Pharma International Pty Ltd

INN (International Name):

Amisulpride

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: sodium starch glycollate type A; microcrystalline cellulose; methylcellulose; magnesium stearate; lactose monohydrate

Administration route:

Oral

Units in package:

90, 50, 60, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.

Product summary:

Visual Identification: White to off-white 11.0 mm round flat tablets, with break line on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2011-11-03