AROPAX CR paroxetine 25mg (as hydrochloride hemihydrate) modified release tablet

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

paroxetine hydrochloride hemihydrate, Quantity: 28.51 mg (Equivalent: paroxetine, Qty 25 mg)

Disponible des:

Aspen Pharmacare Australia Pty Ltd

Designació comuna internacional (DCI):

paroxetine hydrochloride hemihydrate

formulario farmacéutico:

Tablet, modified release

Composición:

Excipient Ingredients: lactose monohydrate; hypromellose; povidone; silicon dioxide; magnesium stearate; glyceryl behenate; iron oxide red; methacrylic acid copolymer; purified talc; triethyl citrate; titanium dioxide; polysorbate 80; macrogol 400; vat red 1

Vía de administración:

Oral

Unidades en paquete:

7 tablets - sample pack, 30 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

AROPAX CR is indicated for the treatment of major depressive disorder and panic disorder, social anxiety disorder/social phobia and treatment of premenstrual dysphoric disorder. AROPAX CR has not been evaluated beyond 12 weeks, 10 weeks, 12 weeks and 3 menstrual cycles in controlled clinical trails for the treatment of major depression, panic disorder, social anxiety disorder and premenstrual dysphoric disorder, respectively.

Resumen del producto:

Visual Identification: Pink, round, biconvex film-coated tablet with bevelled edges. One side engraved with "GSK", the other with "25".; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

2004-05-27