PREZISTA 100mg/ml oral suspension.
PREZISTA 75 mg film-coated tablets.
PREZISTA 150 mg film-coated tablets.
PREZISTA 400 mg film-coated tablets.
PREZISTA 600 mg film-coated tablets.
Oral suspension: White to off-white opaque suspension.
Film-coated tablet:
White caplet shaped tablet of 9.2 mm, debossed with “75” on one side and “TMC” on the other side.
White oval shaped tablet of 13.7 mm, debossed with “150” on one side and “TMC” on the other side.
Light orange oval shaped of 19.1 mm tablet, debossed with “400MG” on one side and “TMC” on the other side.
Orange oval shaped tablet of 21.1 mm, debossed with “600MG” on one side and “TMC” on the other side.
Each ml of oral suspension contains 100 mg of darunavir (as ethanolate).
Excipient with known effect: sodium methyl parahydroxybenzoate (E219) 3.43 mg/ml.
Each film-coated tablet contains 75 mg of darunavir (as ethanolate).
Each film-coated tablet contains 150 mg of darunavir (as ethanolate).
Each film-coated tablet contains 400 mg of darunavir (as ethanolate).
Excipient with known effect: Each tablet contains 0.834 mg sunset yellow FCF (E110).
Each film-coated tablet contains 600 mg of darunavir (as ethanolate).
Excipient with know effect: Each tablet contains 2.750 mg sunset yellow FCF (E110).
For the full list of excipients, see section 6.1.
Hydroxypropylcellulose
Microcrystalline cellulose
Carmellose sodium
Citric acid monohydrate
Sucralose
Strawberry cream flavour
Masking flavour:
Sodium methyl parahydroxybenzoate (E219)
Hydrocholoric acid (for pH adjustment)
Purified water
Tablet core:
Microcrystalline cellulose
Colloidal anhydrous silica
Crospovidone
Magnesium stearate
Tablet film-coat:
Poly(vinyl alcohol) – partially hydrolysed
Macrogol 3350
Titanium dioxide (E171)
Talc
Sunset yellow FCF (E110)(400mg and 600mg tablets only)
Amber-coloured multiple-dose glass bottle for 200 ml suspension with a polypropylene closure with LDPE liner packaged with a 6 ml oral dosing pipette with 0.2 ml gradations. The bottle neck is filled with a low density polyethylene (LDPE) insert that accomodates the dosing pipette.
PREZISTA oral suspension is available in packs of one bottle.
Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 480 tablets, fitted with polypropylene (PP) child resistant closure.
One bottle.
Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 240 tablets, fitted with polypropylene (PP) child resistant closure.
One bottle.
Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 60 tablets, fitted with polypropylene (PP) child resistant closure.
One bottle.
Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 60 tablets, fitted with polypropylene (PP) child resistant closure.
One bottle.
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
EU/1/06/380/006
EU/1/06/380/005
EU/1/06/380/004
EU/1/06/380/003
EU/1/06/380/002
Date of first authorisation: 12 February 2007
Date of latest renewal: 12 February 2009