RALOXIFENE GxP Raloxifene hydrochloride 60 mg tablets, 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)
27-11-2017

Aktivna sestavina:

raloxifene hydrochloride, Quantity: 60 mg

Dostopno od:

MedTAS Pty Ltd

INN (mednarodno ime):

Raloxifene hydrochloride

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: microcrystalline cellulose; crospovidone; magnesium stearate; glycine; colloidal anhydrous silica; polysorbate 80; povidone; titanium dioxide; hypromellose; Carnauba Wax; macrogol 400

Pot uporabe:

Oral

Enote v paketu:

28 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Raloxifene is indicated for the prevention and treatment of osteoporosis in post-menopausal women.,Raloxifene is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis.Raloxifene is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer.

Povzetek izdelek:

Visual Identification: White to off-white, oval, biconvex, film coated tablets with 'C' on one side and '12' on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2014-01-14