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

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

entecavir monohydrate, Quantity: 1.064 mg

Commercializzato da:

Cipla Australia Pty Ltd

INN (Nome Internazionale):

entecavir monohydrate

Forma farmaceutica:

Tablet, film coated

Composizione:

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

Via di somministrazione:

Oral

Confezione:

10, 30

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

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.

Dettagli prodotto:

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

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2016-12-19