DARUNAVIR MYLAN darunavir 800 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

darunavir, Quantity: 800 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Darunavir

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium starch glycollate type A; hypromellose; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; crospovidone; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adult patients:,Darunavir (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adult patients.,Paediatric patients:,Darunavir (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

Product summary:

Visual Identification: White to off-white, oval shaped, biconvex film coated tablets debossed with M on one side of the tablet and DV8 on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2017-05-26