Canada· CA-DIN-02370468

SAMSCA

A tolvaptan product containing tolvaptan, registered in Canada by OTSUKA PHARMACEUTICAL CO LTD. The same ATC class is registered in 13 of our 19 countries.

ATC C03XA01

Checked against Health Canada Drug Product Database (Canada) on

Informational only — not a medical device.

SOURCE REGISTER · CAHealth Canada Drug Product Database (Ca…normalisedSAMSCAATCC03XA01REGISTER NO.CA-DIN-02370468PACKS LISTED0CHECKEDOctober 1, 2026

Where it is registered

Tolvaptan is registered in 13 of 19 countries.

Countries holding a registration under ATC C03XA01 (tolvaptan), each read from that country’s own register.

  • This record: Canada, from Health Canada Drug Product Database (Canada)
  • 8 of them publish a price we can compare per daily dose

Tolvaptan · ATC C03XA01

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of tolvaptan costs, country by country.

Normalised to the WHO defined daily dose (30 mg), the median price runs from $1.82 in Czechia to $127.86 in Italy — a ×70 gap.

  • 4 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Tolvaptan · price per daily dose (30 mg)

USD · FX 28 Sept 2026

  • IT Italy$127.86
  • CH Switzerland$72.80
  • FR France$14.28
  • CZ Czechia$1.82
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

Health Canada Drug Product Database (Canada)
Active substance
TOLVAPTAN
Manufacturer
OTSUKA PHARMACEUTICAL CO LTD
Country
Canada (CA)
ATC code
C03XA01
ATC class
Tolvaptan
Defined daily dose
30 mg, O
Reimbursed
Not published by this register
Source register
Health Canada Drug Product Database (Canada)
Last checked
October 1, 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.

Interactions

183 interactions on record for tolvaptan.

Graded by severity as the source publishes them — 16 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Tolvaptan · interactions on record

183 records

  • 16 severe
  • 161 moderate
  • 6 minor

Most severe, free to view

  • KetoconazoleH02CA03severe
  • ClarithromycinJ01FA09severe
  • KetoconazoleJ02AB02severe
  • Darunavir and cobicistatJ05AR14severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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 21 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
  • 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 Health Canada Drug Product Database (Canada). 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/e245537b-d68a-4ced-a037-154525a774ec
GET /v1/drugs/e245537b-d68a-4ced-a037-154525a774ec?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.

{
  "din": "02370468",
  "form": "TABLET",
  "class": "Human",
  "routes": [
    "ORAL"
  ],
  "source": "health_canada_dpd",
  "status": "MARKETED",
  "atc_raw": "C03XA01",
  "schedule": [
    "Prescription"
  ],
  "drug_code": "85561",
  "strengths": [
    "15 MG"
  ],
  "ahfs_class": null,
  "substances": [
    "TOLVAPTAN"
  ],
  "product_categorization": null
}

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.