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Medicines
Spain
Dolutegravir

AEMPS 2017

Dolutegravir

Tivicay 10 MG Comprimidos Recubiertos con Pelicula

10.50 mg comprimido recubierto con películaSpainMarketedAuthorised 14 Mar 2017

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.

TivicayBrazil · Glaxosmithkline Brasil LtdaSame brand
Tivicay PDBrazil · Glaxosmithkline Brasil LtdaSame brand
TivicayCanada · 50 MG · Tablet · Viiv Healthcare UlcSame brand
TivicayCanada · 5 MG · Tablet For Suspension · Viiv Healthcare UlcSame brand
TivicayCanada · 10 MG · Tablet · Viiv Healthcare UlcSame brand
TivicayEuropean Union · ViiV Healthcare BVSame brand
TivicayCroatiaSame brand
TivicayItaly · Compressa rivestita con film · Viiv Healthcare BVSame brand

More with the same substance on this register

Tivicay 5 MG Comprimidos DispersablesDolutegravir · 5,26 mg · comprimido dispersableSpain
Tivicay 50 MG Comprimidos Recubiertos con PeliculaDolutegravir · 52,6 mg · comprimido recubierto con películaSpain

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.

🇳🇱Tivicay 10 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · ViiV healthcare B.V.Same brand

🇳🇱Tivicay 25 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · ViiV healthcare B.V.Same brand

🇳🇱Tivicay 5 mg oplosbare tablettenNetherlands · Oplosbare tablet · ViiV healthcare B.V.Same brand

🇳🇿TivicayNew Zealand · Tab 50 mgSame brand

🇷🇴TIVICAY 10 mgRomania · 10mg · compr. film. · Viiv Healthcare BVSame brand

🇷🇴TIVICAY 10mgRomania · 10mg · compr. film. · Viiv Healthcare UK LimitedSame brand

🇷🇴TIVICAY 25 mgRomania · 25mg · compr. film. · Viiv Healthcare BVSame brand

🇷🇸Tivicay®Serbia · 50mg · film tableta · Evropa Lek Pharma D.O.O. BeogradSame brand

🇷🇸Tivicay®Serbia · 50mg · film tableta · Evropa Lek Pharma D.O.O. BeogradSame brand

🇸🇦TIVICAY 50 mg TabletSaudi Arabia · Delpharm Poznań Spółka AkcyjnaSame brand

🇸🇬Tivicay Dispersible Tablet 5 MGSingapore · 5.00 mg · tablet, for suspension · Glaxosmithkline Pte LTDSame brand

🇸🇬Tivicay Tablet 50MGSingapore · 50mg · tablet, film coated · Glaxosmithkline Pte LTDSame brand

🇺🇸TivicayUnited States · 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 50MG BASE · tablet · Viiv HlthcareSame brand

🇺🇸Tivicay PDUnited States · 5MG BASE · tablet, for suspension · Viiv HlthcareSame brand

🇭🇷Dolutegravir Teva 50 mg filmom obložene tableteCroatia · Filmom obložena tableta · TEVA GmbH, Graf-Arco-Strasse 3, Ulm, NjemačkaSame form

🇺🇸Dolutegravir SodiumUnited States · 10MG · tablet · Macleods Pharms LTDSame form

🇧🇷dolutegravir sódicoBrazil · Cristália Produtos Químicos Farmacêuticos Ltda.Same substance

Packs

Pack	Code	Status
TIVICAY 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 30 comprimidos	715365

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: Dolutegravir
Strength: 10.50 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 14 Mar 2017
Registration: 113892003
Marketing authorisation holder: Viiv Healthcare B.V.
Procedure: EU centralised
Supply: Diagnóstico Hospitalario

🇪🇸

AEMPSTivicay 25 MG Comprimidos Recubiertos con PeliculaDolutegravir · 26,30 mg · comprimido recubierto con película🇪🇸Spain