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Medicines
Spain
Darunavir

AEMPS 2013

Darunavir

Prezista 800 MG Comprimidos Recubiertos con Pelicula

867,28 mg comprimido recubierto con películaSpainMarketedAuthorised 20 Feb 2013

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

PrezistaBrazil · Janssen-Cilag Farmacêutica LtdaSame brand
PrezistaCanada · 400 MG · Tablet · Janssen INCSame brand
PrezistaCanada · 800 MG · Tablet · Janssen INCSame brand
PrezistaCanada · 150 MG · Tablet · Janssen INCSame brand
PrezistaEuropean Union · Janssen-Cilag International NVSame brand
PrezistaCroatiaSame brand
PrezistaItaly · Compressa rivestita con film · Janssen-Cilag International N.V.Same brand
Prezista 150 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NV

More with the same substance on this register

Darunavir Sandoz 600 MG Comprimidos Recubiertos con Pelicula EfgDarunavir · 600 mg · comprimido recubierto con películaSpain
Darunavir Sandoz 800 MG Comprimidos Recubiertos con Pelicula EfgDarunavir · 800 mg · comprimido recubierto con película

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Same brand

🇳🇱Prezista 400 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NVSame brand

🇳🇱Prezista 600 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NVSame brand

🇷🇴PREZISTA 100 mg/mlRomania · 100mg/ml · susp. orala · JanssenSame brand

🇷🇴PREZISTA 150 mgRomania · 150mg · compr. film. · JanssenSame brand

🇷🇴PREZISTA 75 mgRomania · 75mg · compr. film. · JanssenSame brand

🇸🇦Prezista 300MG F.C. TabletsSaudi Arabia · Janssen - OrthoSame brand

🇸🇦PREZISTA 400 mg film-coated tabletSaudi Arabia · Janssen-Cilag SPASame brand

🇸🇦PREZISTA 600 mg film-coated tabletSaudi Arabia · Janssen-Cilag SPASame brand

🇸🇬Prezista™ Tablet 150MGSingapore · 150mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTDSame brand

🇸🇬Prezista™ Tablet 400MGSingapore · 400mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTDSame brand

🇸🇬Prezista™ Tablet 600MGSingapore · 600mg + 600mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTDSame brand

🇹🇼Prezista Film Coated Tablets 300mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same brand

🇹🇼Prezista® Tablets 150mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same brand

🇹🇼Prezista® Tablets 400mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same brand

🇺🇸PrezistaUnited States · 150MG, 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** … · tablet · Janssen ProdsSame brand

🇺🇸PrezistaUnited States · 100MG/ML · suspension · Janssen ProdsSame brand

🇭🇷Darunavir Sandoz 800 mg filmom obložene tableteCroatia · filmom obložena tableta · Sandoz d.o.o., Maksimirska 120, Zagreb, HrvatskaSame form

🇮🇹Darunavir AurobindoItaly · Compressa rivestita con film · Aurobindo Pharma (Italia) S.R.L.Same form

🇮🇹Darunavir KrkaItaly · Compressa rivestita con film · Krka D.D. Novo MestoSame form

🇳🇿Darunavir ViatrisNew Zealand · Tab 600 mgSame form

🇳🇿Darunavir ViatrisNew Zealand · Tab 400 mgSame form

🇷🇸Darunavir KrkaSerbia · 600mg · film tableta · Krka-Farma D.O.O. BeogradSame form

🇷🇸Darunavir KrkaSerbia · 800mg · film tableta · Krka-Farma D.O.O. BeogradSame form

🇺🇸DarunavirUnited States · 150MG, 300MG, 400MG … · tablet · Aurobindo Pharma LTDSame form

🇧🇷darunavirBrazil · Viatris Farmaceutica do Brasil LtdaSame substance

🇧🇷darunavirBrazil · Laboratorio Farmaceutico do Estado de Pernambuco Governador Miguel Arraes S/A - LafepeSame substance

🇪🇺Darunavir KrkaEuropean Union · KRKA, d.d., Novo mestoSame substance

🇪🇺Darunavir Viatris (previously Darunavir Mylan)European Union · Viatris LimitedSame substance

🇭🇷Darunavir MylanCroatiaSame substance

Packs

Pack	Code	Status
PREZISTA 800 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 30 comprimidos	696942

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Darunavir
Strength: 867,28 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 20 Feb 2013
Registration: 106380007
Marketing authorisation holder: Janssen-Cilag International N.V
Procedure: EU centralised
Supply: Diagnóstico Hospitalario

🇪🇸Spain

AEMPSDarunavir Tarbis 400 MG Comprimidos Recubiertos con Pelicula EfgDarunavir · 400 mg · comprimido recubierto con película🇪🇸Spain

AEMPSDarunavir Tarbis 600 MG Comprimidos Recubiertos con Pelicula EfgDarunavir · 600 mg · comprimido recubierto con película🇪🇸Spain

AEMPSDarunavir Tarbis 800 MG Comprimidos Recubiertos con Pelicula EfgDarunavir · 800 mg · comprimido recubierto con película🇪🇸Spain

AEMPSDarunavir Vivanta 600 MG Comprimidos Recubiertos con Pelicula EfgDarunavir · 600 mg · comprimido recubierto con película🇪🇸Spain

AEMPSDarunavir Vivanta 800 MG Comprimidos Recubiertos con Pelicula EfgDarunavir · 800 mg · comprimido recubierto con película🇪🇸Spain

AEMPSPrezista 100 MG/ML Suspension OralDarunavir · 108.4 mg · suspensión oral🇪🇸Spain

AEMPSPREZISTA 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULADarunavir · 400 mg · comprimido recubierto con película🇪🇸Spain

AEMPSPREZISTA 600 mg COMPRIMIDOS RECUBIERTOS CON PELICULADarunavir · 600 mg · comprimido recubierto con película🇪🇸Spain

AEMPSDarunavir Krka 400 MG Comprimidos Recubiertos con Peliculas EfgDarunavir · 400 mg · comprimido recubierto con película🇪🇸Spain

AEMPSDarunavir Krka 600 MG Comprimidos Recubiertos con Pelicula EfgDarunavir · 600 mg · comprimido recubierto con película🇪🇸Spain