GenRx Entecavir entecavir (as monohydrate) 0.5mg tablet 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:

entecavir, Quantity: 0.5 mg

Dostopno od:

Arrotex Pharmaceuticals Pty Ltd

INN (mednarodno ime):

Entecavir

Farmacevtska oblika:

Tablet

Sestava:

Excipient Ingredients: lactose monohydrate; magnesium stearate; macrogol 8000; microcrystalline cellulose; hyprolose; copovidone; hypromellose; crospovidone; titanium dioxide

Pot uporabe:

Oral

Enote v paketu:

30

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation.,This indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.

Povzetek izdelek:

Visual Identification: White colored, triangular shaped film coated tablets, engraved 'APO' on one side and '0.5' over 'ENT' on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2016-03-10