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Prezista 75 mg, 150 mg, 400 mg, 600 mg film-coated tablets and Oral suspension 100mg/ml (2012)

Active ingredients: Darunavir

Product Name and Form

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.

Qualitative and Quantitative Composition

100mg/ml oral suspension

Each ml of oral suspension contains 100 mg of darunavir (as ethanolate).

Excipient with known effect: sodium methyl parahydroxybenzoate (E219) 3.43 mg/ml.

75 mg film-coated tablet

Each film-coated tablet contains 75 mg of darunavir (as ethanolate).

150 mg film-coated tablet

Each film-coated tablet contains 150 mg of darunavir (as ethanolate).

400 mg film-coated tablet

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).

600 mg film-coated tablet

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.

Chemical substance
Description
Darunavir

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 suspension

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

Tablets

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)

Pack sizes and Marketing

Oral suspension

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.

75mg tablets

Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 480 tablets, fitted with polypropylene (PP) child resistant closure.

One bottle.

150mg tablets

Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 240 tablets, fitted with polypropylene (PP) child resistant closure.

One bottle.

400mg tablets

Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 60 tablets, fitted with polypropylene (PP) child resistant closure.

One bottle.

600mg tablets

Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 60 tablets, fitted with polypropylene (PP) child resistant closure.

One bottle.

Marketing authorization holder
Authorization dates

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Date of first authorisation: 12 February 2007

Date of latest renewal: 12 February 2009

Marketing authorization number:

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