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Medicines
Spain
Tolvaptan

AEMPS 2009

Tolvaptan

SAMSCA 15 mg. COMPRIMIDOS

15 mg comprimidoSpainAuthorisedAuthorised 15 Sept 2009

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.

SamscaCanada · 30 MG · Tablet · Otsuka Pharmaceutical Co LTDSame brand
SamscaCanada · 15 MG · Tablet · Otsuka Pharmaceutical Co LTDSame brand
SamscaCanada · 60 MG · Tablet · Otsuka Pharmaceutical Co LTDSame brand
SamscaEuropean Union · Otsuka Pharmaceutical Netherlands B.V.Same brand
SamscaCroatiaSame brand
SamscaItaly · Compressa · Otsuka Pharmaceutical Netherlands BVSame brand
Samsca 15 mg tablettenNetherlands · Tablet · Otsuka Pharmaceutical Netherlands B.V.Same brand
Samsca 30 mg tabletten

More with the same substance on this register

JINARC 15 mg + 45 mg COMPRIMIDOSTolvaptan · 45 mg + 15 mg · comprimidoSpain
JINARC 15 mg COMPRIMIDOSTolvaptan · 15 mg · comprimidoSpain

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.

Netherlands · Tablet · Otsuka Pharmaceutical Netherlands B.V.

Same brand

🇳🇱Samsca 7,5 mg tablettenNetherlands · Tablet · Otsuka Pharmaceutical Netherlands B.V.Same brand

🇸🇬Samsca Tablet 15MGSingapore · 15mg · tablet · Otsuka Pharmaceuticals (Singapore) Pte. LTD.Same brand

🇺🇸SamscaUnited States · 15MG, 30MG, 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet · OtsukaSame brand

🇭🇷Gurdatol 15 mg i 45 mg tableteCroatia · Tableta · Sandoz d.o.o., Maksimirska 120, Zagreb, HrvatskaSame form

🇭🇷Gurdatol 15 mg tableteCroatia · Tableta · Sandoz d.o.o., Maksimirska 120, Zagreb, HrvatskaSame form

🇮🇹JinarcItaly · Compressa · Otsuka Pharmaceutical Netherlands BVSame form

🇮🇹Tolvaptan AccordItaly · Compressa · Accord Healthcare, S.L.U.Same form

🇳🇿JinarcNew Zealand · Tab 90 mg + 30 mgSame form

🇳🇿JinarcNew Zealand · Tab 30 mgSame form

🇳🇿JinarcNew Zealand · Tab 60 mg + 30 mgSame form

🇸🇬Jinarc Tablet 15MGSingapore · 15mg · tablet · Otsuka Pharmaceuticals (Singapore) Pte. LTD.Same form

🇸🇬Jinarc Tablet 30MGSingapore · 30.000mg · tablet · Otsuka Pharmaceuticals (Singapore) Pte. LTD.Same form

🇺🇸JynarqueUnited States · 15MG, 30MG, 45MG … · tablet · OtsukaSame form

🇺🇸TolvaptanUnited States · 15MG, 30MG, 45MG … · tablet · Alkem Labs LTDSame form

🇪🇺JinarcEuropean Union · Otsuka Pharmaceutical Netherlands B.V.Same substance

🇪🇺Tolvaptan AccordEuropean Union · Accord Healthcare S.L.U.Same substance

🇷🇴JINARC 15mg + JINARC 45mgRomania · compr. · Otsuka Pharmaceutical Netherlands B.V.Same substance

🇷🇴JINARC 30mg + JINARC 60mgRomania · compr. · Otsuka Pharmaceutical Netherlands B.V.Same substance

🇷🇴JINARC 30mg + JINARC 90mgRomania · compr. · Otsuka Pharmaceutical Netherlands B.V.Same substance

🇸🇦VaprenaSaudi Arabia · Jiangsu Hengrui Pharmaceuticals Co LtdSame substance

Packs

Pack	Code	Status
SAMSCA 15 mg. COMPRIMIDOS, 30 comprimidos	663725

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: Tolvaptan
Strength: 15 mg
Dosage form: comprimido
Route: vía oral
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 15 Sept 2009
Registration: 09539002
Marketing authorisation holder: Otsuka Pharmaceutical Netherlands B.V.
Procedure: EU centralised
Supply: Medicamento Sujeto A Prescripción Médica

AEMPS

JINARC 30 mg + 60 mg comprimidosTolvaptan · 60 mg + 30 mg · comprimido🇪🇸Spain

AEMPSJINARC 30 mg + 90 mg COMPRIMIDOSTolvaptan · 90 mg + 30 mg · comprimido🇪🇸Spain

AEMPSJINARC 30 mg COMPRIMIDOSTolvaptan · 30 mg · comprimido🇪🇸Spain

AEMPSSAMSCA 15 mg COMPRIMIDOSTolvaptan · 10 mg · comprimido🇪🇸Spain

AEMPSSAMSCA 30 mg COMPRIMIDOSTolvaptan · 30 mg · comprimido🇪🇸Spain

AEMPSSamsca 7,5 MG ComprimidosTolvaptan · 7, 50 mg · comprimido🇪🇸Spain

AEMPSTolvaptan Accord 15 MG Comprimidos EfgTolvaptan · 15 mg · comprimido🇪🇸Spain

AEMPSTolvaptan Accord 30 MG Comprimidos EfgTolvaptan · 30 mg · comprimido🇪🇸Spain

AEMPSTolvaptan Accord 7,5 MG Comprimidos EfgTolvaptan · 7,5 mg · comprimido🇪🇸Spain

AEMPSTolvaptan Teva 15 MG Comprimidos EfgTolvaptan · 15 mg · comprimido🇪🇸Spain