Poland· PL-100523129
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.
Checked against URPL (Poland) on
Informational only — not a medical device.
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
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
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
- gtin07622436147789
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.
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.
- IcelandGurdatolSandoz A/S
- United KingdomJinarc 15mg tabletsOtsuka Pharmaceuticals (U.K.) Ltd
- CzechiaJINARCOtsuka Pharmaceutical Netherlands B.V., Amsterdam
- United StatesJYNARQUEOtsuka America Pharmaceutical, Inc.
- SpainJINARC 15 mg + 45 mg COMPRIMIDOSOtsuka Pharmaceutical Netherlands B.V.
- SwedenJinarc 15 mg TablettOtsuka Pharmaceutical Netherlands B.V.
- NorwayJinarcOtsuka Pharmaceutical Netherlands B.V.
- NetherlandsJinarc 15 mg, tabletOtsuka Pharmaceutical Netherlands B.V.
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/aa4c46b0-f31b-4a96-a032-3974e5b48c9b GET /v1/drugs/aa4c46b0-f31b-4a96-a032-3974e5b48c9b?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": "15 mg; 45 mg",
"packaging": "07622436147789 ¦ Rpz ¦ 165574\n28 tabl. 15 mg ¦ 28 tabl. 45 mg",
"substance": "Tolvaptanum 15 mg; 45 mg",
"common_name": "Tolvaptanum",
"pl_product_id": "100523129",
"pozwolenie_nr": "29627",
"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.