DULOXETINE-RZ Duloxetine (as hydrochloride) 30 mg enteric capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

duloxetine hydrochloride, Quantity: 33.65 mg (Equivalent: duloxetine, Qty 30 mg)

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

Duloxetine hydrochloride

Pharmaceutical form:

Capsule, enteric

Composition:

Excipient Ingredients: triethyl citrate; glycine; purified talc; hypromellose; sucrose; hypromellose phthalate; maize starch; titanium dioxide; brilliant blue FCF; purified water; allura red AC; Gelatin; acetic acid; silicon dioxide; sodium lauryl sulfate; citric acid; propylene glycol; butan-1-ol; ethanol; isopropyl alcohol; iron oxide yellow; Shellac; strong ammonia solution

Administration route:

Oral

Units in package:

10's, 28's, 7's, 14's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indications,1. Treatment of major depressive disorder (MDD),2. Treatment of diabetic peripheral neuropathic pain (DPNP),3. Treatment of generalised anxiety disorder (GAD)

Product summary:

Visual Identification: Size '3' hard gelatin capsule with opaque blue coloured cap and opaque white body, imprinted 'RDY609' on cap and '30 mg' on body with golden yellow ink; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-06-19