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Medicines
Spain
Sofosbuvir

AEMPS 2014

Sofosbuvir

SOVALDI 400mg comprimidos recubiertos con pelicula

400 mg comprimido recubierto con películaSpainMarketedAuthorised 4 Mar 2014

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.

SovaldiBrazil · Gilead Sciences Farmaceutica do Brasil LtdaSame brand
SovaldiCanada · 400 MG · Tablet · Gilead Sciences Canada INCSame brand
SovaldiEuropean Union · Gilead Sciences Ireland UCSame brand
SovaldiCroatiaSame brand
SovaldiItaly · Compressa rivestita con film · Gilead Sciences Ireland UcSame brand
Sovaldi 200 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · Gilead Sciences Ireland UCSame brand
Sovaldi 400 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Gilead Sciences Ireland UCSame brand

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.

🇳🇱

Sovaldi 150 mg, granulaatNetherlands · Granulaat · Gilead Sciences Ireland UC

Same brand

🇸🇦SOVALDI 400 mg film-coated tabletSaudi Arabia · Gilead Sciences Ireland UcSame brand

🇺🇸SovaldiUnited States · 200MG, 400MG · tablet · Gilead Sciences INCSame brand

🇺🇸SovaldiUnited States · 150MG/PACKET, 200MG/PACKET · pellets · Gilead Sciences INCSame brand

🇸🇦SOFOCURE 400 mg film-coated tabletSaudi Arabia · European Egyptian Pharmaceutical Ind. CoSame form

🇸🇦SOVIRA 400 mg film-coated tabletSaudi Arabia · SpimacoSame form

🇺🇸SofosbuvirUnited States · 400MG · tablet · Teva Pharms USA INCSame form

🇧🇷sofosbuvirBrazil · Fundação Oswaldo CruzSame substance

🇧🇷sofosbuvirBrazil · Fundação Para O Remédio Popular - FurpSame substance

Packs

Pack	Code	Status
SOVALDI 400mg comprimidos recubiertos con pelicula , 28 COMPRIMIDOS	701697

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: Sofosbuvir
Strength: 400 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 4 Mar 2014
Registration: 113894001
Marketing authorisation holder: Gilead Sciences Ireland Unlimited Company
Procedure: EU centralised
Supply: Diagnóstico Hospitalario