CIPLA ENTECAVIR entecavir (as monohydrate) 1mg film coated tablets

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
24-11-2017

Aktivna sestavina:

entecavir monohydrate, Quantity: 1.064 mg

Dostopno od:

Cipla Australia Pty Ltd

INN (mednarodno ime):

entecavir monohydrate

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; crospovidone; hyprolose; titanium dioxide; hypromellose; iron oxide red; macrogol 400

Pot uporabe:

Oral

Enote v paketu:

10, 30

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

CIPLA 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: pink coloured, triangular shaped, biconvex, film coated tablet, debossed with 'E' on one side and "1" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Licence status A

Datum dovoljenje:

2016-12-19