Dutasteride APOTEX dutasteride 500 microgram soft capsule blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
26-11-2017

Aktivna sestavina:

dutasteride, Quantity: 500 microgram

Dostopno od:

Arrotex Pharmaceuticals Pty Ltd

INN (mednarodno ime):

Dutasteride

Farmacevtska oblika:

Capsule, soft

Sestava:

Excipient Ingredients: butylated hydroxytoluene; iron oxide yellow; Gelatin; titanium dioxide; glyceryl caprylate/caprate; glycerol; propylene glycol; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; simethicone; ethanol; Shellac; sulfuric acid

Pot uporabe:

Oral

Enote v paketu:

30

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

This medicine is indicated for use as monotherapy for the management of symptomatic benign prostatic,hyperplasia (BPH) or as combination therapy with an alpha blocker which is approved for use in BPH and,which has been dose titrated in accordance with the relevant recommendations in the product information,for that alpha blocker.

Povzetek izdelek:

Visual Identification: An oily colourless to pale yellow liquid absent of visible particles and/or crystals in a pale yellow oblong gelatin capsule printed with with 'A 0.5' on one side in red ink; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2014-02-28