APOTEX-Amisulpride 400 mg tablet blister pack

Active ingredient:

amisulpride, Quantity: 400 mg

Available from:

GM Pharma International Pty Ltd

INN (International Name):

Amisulpride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: titanium dioxide; sodium starch glycollate type A; methylcellulose; magnesium stearate; macrogol 6000; microcrystalline cellulose; lactose monohydrate; purified talc; basic butylated methacrylate copolymer

Administration route:

Oral

Units in package:

100, 50, 60, 10, 90

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, 18 x 8mm capsule shaped, film-coated tablets with breakline 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