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Spain· ES:109539007

SAMSCA 7,5 MG COMPRIMIDOS

A medicinal product containing tolvaptán, registered in Spain by Otsuka Pharmaceutical Netherlands B.V..

Checked against AEMPS CIMA (Spain) on

Informational only — not a medical device.

SOURCE REGISTER · ESAEMPS CIMA (Spain)normalisedSAMSCA 7,5 MG COMPRIMIDOSATC—REGISTER NO.ES:109539007PACKS LISTED0CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about tolvaptánAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

AEMPS CIMA (Spain)
Active substance
tolvaptán
Manufacturer
Otsuka Pharmaceutical Netherlands B.V.
Country
Spain (ES)
ATC code
—
Reimbursed
Not published by this register
Source register
AEMPS CIMA (Spain)
Last checked
September 12, 2026

Packs & prices · 0

No packs listed by the register for this record.

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Tolvaptán in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All tolvaptán products

Authorised across Europe · EMA

The same active substance is authorised in 20 EEA countries. Names it is sold under:

  • Austria · Tolvaptan, Tolvaptan +pharma
  • Belgium · Tolvaptan, Tolvaptan Eg
  • Czechia · Tolvaptan Stada
  • Germany · Tolvaptan, Tolvaptan 1 A Pharma
  • Estonia · Tolvaptan Stada
  • France · Tolvaptan Biogaran, Tolvaptan Eg
  • United Kingdom (Northern Ireland) · Tolvaptan, Tolvaptan Genus Pharmaceuticals
  • Greece · Gurdatol, Pokydy
  • Croatia · Gurdatol
  • Ireland · Tolvaptan Ascend
  • Iceland · Gurdatol, Jinarc
  • Italy · Tolvaptan Teva, Tolvaptan Teva Italia
  • Liechtenstein · Jinarc, Samsca
  • Lithuania · Tolvaptan Stada
  • Latvia · Tolvaptan Stada
  • Netherlands · Tolvaptan Sandoz, Tolvaptan Teva
  • Norway · Jinarc, Samsca
  • Poland · Tolvaptan Sandoz
  • Portugal · Tolvaptano Stada, Tolvaptano Stada 15 Mg + 45 Mg Comprimidos
  • Sweden · Tolvaptan Hexal, Tolvaptan Sandoz

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of AEMPS CIMA (Spain). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/021fb876-5718-40d0-9e16-2b1c0d2ee796
GET /v1/drugs/021fb876-5718-40d0-9e16-2b1c0d2ee796?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "cpresc": "Medicamento Sujeto A Prescripción Médica",
  "estado": "{\"aut\":1612358050000}",
  "nregistro": "109539007",
  "substance": "tolvaptán"
}
API referenceMCP serverPlans

See everything about tolvaptán.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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