What PREZISTA contains
- The active substance is darunavir. Each tablet contains 75 mg of darunavir as ethanolate.
- The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate. The film-coating contains poly(vinyl alcohol) - partially hydrolyzed, macrogol 3350, titanium dioxide (E171), talc.
What PREZISTA looks like and contents of the pack
Film-coated, white, caplet shaped tablet, mentioning TMC on one side, 75 on the other side. 480 tablets in a plastic bottle.
PREZISTA is also available as 150 mg, 300 mg, 400 mg and 600 mg film-coated tablets.
Marketing Authorisation Holder
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Manufacturer
Janssen-Cilag SpA, Via C. Janssen, 04010 Borgo San Michele, Latina, Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien TIBOTEC, een divisie van, une division de, eine Division der JANSSEN-CILAG NVSA Antwerpseweg 15-17 B-2340 Beerse TelTél 32 14 64 94 11 LuxembourgLuxemburg TIBOTEC, une division de, eine Division der JANSSEN-CILAG NVSA Antwerpseweg 15-17 B-2340 Beerse BelgiqueBelgien TélTel 32 14 64 94 11
Magyarország TIBOTEC, a JANSSEN-CILAG Kft. divíziója H-2045 Törökbálint, Tó Park Tel 36 23 513 800 TIBOTEC, Johnson Johnson, d.o.o. .. 4 , 4 1766 . 359 2 489 94 00
eská republika TIBOTEC, divize JANSSEN-CILAG s.r.o. Karla Englie 320106 CZ-150 00 Praha 5 - Smíchov Tel 420 227 012 222 Malta AM MANGION LTD. Mangion Building, Triq dida fi Triq Valletta MT-al-Luqa LQA 6000 Tel 356 2397 6000
Danmark TIBOTEC, en division af JANSSEN-CILAG AS Hammerbakken 19 DK-3460 Birkerød Tlf 45 45 94 82 82 Nederland TIBOTEC, een divisie van JANSSEN-CILAG B.V. Postbus 90240 NL-5000 LT Tilburg Tel 31 13 583 73 73
Deutschland JANSSEN-CILAG GmbH Johnson Johnson Platz 1 D-41470 Neuss Tel 49 2137 955-955 Norge TIBOTEC, en divisjon av JANSSEN-CILAG AS Drammensveien 288 N-0283 Oslo Tlf 47 24 12 65 00
Eesti TIBOTEC, JANSSEN-CILAG Polska Sp. z o.o. Eesti filiaal Lõõtsa 2 EE-11415 Tallinn Tel 372 617 7410 Österreich TIBOTEC, eine Division von JANSSEN-CILAG Pharma GmbH Pfarrgasse 75 A-1232 Wien Tel 43 1 610 300
TIBOTEC, JANSSEN-CILAG .... 56 GR-151 21 , T 30 210 80 90 000 Polska TIBOTEC, oddzia JANSSEN-CILAG Polska Sp. z o.o. ul. Iecka 24 PL-02-135 Warszawa Tel 48 22 237 60 00
España JANSSEN-CILAG, S.A. división TIBOTEC Paseo de las Doce Estrellas, 5-7 Campo de las Naciones E-28042 Madrid Tel 34 91 722 81 00 Portugal TIBOTEC, uma divisão da JANSSEN-CILAG FARMACÊUTICA, LDA. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo PT-2734-503 Barcarena Tel 351 21 43 68 835
France TIBOTEC, une division de JANSSEN-CILAG 1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél 0 800 25 50 75 33 1 55 00 44 44 România TIBOTEC, subsidiar a Janssen-Cilag, Johnson Johnson d.o.o. Strada Tipografilor nr. 11-15, Cldirea S-Park, corp A2, etaj 5 013714 Bucureti Tel 40 21 2 071 800
Ireland TIBOTEC, a division of JANSSEN-CILAG Ltd. 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG - UK Tel 44 1494 567 444 Slovenija TIBOTEC za Janssen-Cilag, del JohnsonJohnson d.o.o. martinska cesta 53 SI-1000 Ljubljana Tel 386 1 401 18 30
Slovenská republika TIBOTEC, divízia Johnson Johnson s.r.o. Plynárenská 7B SK-824 78 Bratislava Tel 421 233 552 600 Ísland TIBOTEC, deild hjá JANSSEN-CILAG co Vistor hf. Hörgatún 2 IS-210 Garðabær Sími 354 535 7000
Italia TIBOTEC, una divisione di JANSSEN-CILAG SpA Via M. Buonarroti, 23 I-20093 Cologno Monzese MI Tel 39 02 2510 1 SuomiFinland TIBOTEC JANSSEN-CILAG OY VaisalantieVaisalavägen 2 FI-02130 EspooEsbo PuhTel 358 207 531 300
, 7 CY-1060 357 22 755 214 Sverige TIBOTEC, en division inom JANSSEN-CILAG AB Box 7073 S-192 07 Sollentuna Tel 46 8 626 50 00
Latvija TIBOTEC, JANSSEN-CILAG Polska Sp. z o.o. filile Latvij Bauskas iela 58A-3 Rga, LV 1004 Tel 371 678 93561 United Kingdom TIBOTEC, a division of JANSSEN-CILAG Ltd. 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG - UK Tel 44 1494 567 444
Lietuva
UAB ?Johnson & Johnson?
Gele-inio Vilko g. 18A
LT-08104 Vilnius
Tel: +370 5 278 68 88
This leaflet was last approved in {MM/YYYY}.