Poland· PL-100523136

Tolvaptan Sandoz

A tolvaptan product containing tolvaptanum, registered in Poland by Sandoz Polska Sp. z o.o.. The same ATC class is registered in 13 of our 19 countries.

ATC C03XA01

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedTolvaptan SandozATCC03XA01REGISTER NO.PL-100523136PACKS LISTED1CHECKEDSeptember 27, 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: Poland, from URPL (Poland)
  • 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

URPL (Poland)
Active substance
Tolvaptanum
Manufacturer
Sandoz Polska Sp. z o.o.
Country
Poland (PL)
ATC code
C03XA01
ATC class
Tolvaptan
Defined daily dose
30 mg, O
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 1

  • gtin
    07622436147796

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 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
  • 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 URPL (Poland). 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/fc47838e-a0a7-4b01-9b14-e9048b4f6317
GET /v1/drugs/fc47838e-a0a7-4b01-9b14-e9048b4f6317?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.

{
  "form": "Tabletki",
  "source": "urpl",
  "strength": "30 mg; 60 mg",
  "packaging": "07622436147796 ¦ Rpz ¦ 165575\n28 tabl. 30 mg ¦ 28 tabl. 60 mg",
  "substance": "Tolvaptanum 30 mg; 60 mg",
  "common_name": "Tolvaptanum",
  "pl_product_id": "100523136",
  "pozwolenie_nr": "29628",
  "auth_procedure": "MRP",
  "authorisation_validity": "2031-04-01"
}

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.