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Sweden· SE-20161129000181

Samsca 7,5 mg Tablett

A medicinal product containing tolvaptan, registered in Sweden by Otsuka Pharmaceutical Netherlands B.V..

Checked against Swedish Medical Products Agency (Sweden) on

Informational only — not a medical device.

SOURCE REGISTER · SESwedish Medical Products Agency (Sweden)normalisedSamsca 7,5 mg TablettATC—REGISTER NO.SE-20161129000181PACKS LISTED1CHECKEDOctober 1, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about tolvaptanAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

Swedish Medical Products Agency (Sweden)
Active substance
Tolvaptan
Manufacturer
Otsuka Pharmaceutical Netherlands B.V.
Country
Sweden (SE)
ATC code
—
Reimbursed
Not published by this register
Source register
Swedish Medical Products Agency (Sweden)
Last checked
October 1, 2026

Packs & prices · 1

  • se_varunummer
    20161129000181

Regulatory notes

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

Same medicine, other countries

Tolvaptan in 16 other countries

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

All tolvaptan 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
  • Spain · Tolvaptán Sandoz, Tolvaptan Stadafarma
  • 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

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 Swedish Medical Products Agency (Sweden). 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/9cf3afe8-95bd-4ce0-bd44-73a4fd1706e2
GET /v1/drugs/9cf3afe8-95bd-4ce0-bd44-73a4fd1706e2?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.

{
  "source": "lakemedelsverket",
  "doc_types": [
    "EPAR",
    "EMA"
  ],
  "se_npl_id": "20161129000181",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20161129000181",
  "product_doc_link": "https://www.ema.europa.eu/sv/documents/product-information/samsca-epar-product-information_sv.pdf"
}
API referenceMCP serverPlans

See everything about tolvaptan.

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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