Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium
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.
| Pharmaceutical Form |
|---|
|
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.
| Active Ingredient |
|---|
|
Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 × 10-12 M). It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles. |
| List of Excipients |
|---|
Oral suspensionHydroxypropylcellulose Masking flavour: Sodium methyl parahydroxybenzoate (E219) TabletsTablet core: Microcrystalline cellulose Tablet film-coat: Poly(vinyl alcohol) – partially hydrolysed |
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
| Drug | Countries | |
|---|---|---|
| PREZISTA | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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