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Belgium· BE-AMP-SAM477706-00

Jinarc 30 mg - 60 mg

A tolvaptan product containing tolvaptan, registered in Belgium by Otsuka Pharmaceutical Netherlands. The same ATC class is registered in 13 of our 19 countries.

ATC C03XA01

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedJinarc 30 mg - 60 mgATCC03XA01REGISTER NO.BE-AMP-SAM477706-00PACKS LISTED2CHECKEDSeptember 26, 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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Tolvaptan
Manufacturer
Otsuka Pharmaceutical Netherlands
Country
Belgium (BE)
ATC code
C03XA01
ATC class
Tolvaptan
Defined daily dose
30 mg, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    3451986
  • be_apb
    7716004

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
  • 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 FAMHP / AFMPS (Belgium). 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/b45c7a7c-d0ca-46e6-8726-161318fa41eb
GET /v1/drugs/b45c7a7c-d0ca-46e6-8726-161318fa41eb?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": "Tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Jinarc 30 mg - 60 mg",
  "name_fr": "Jinarc 30 mg - 60 mg",
  "name_nl": "Jinarc 30 mg - 60 mg",
  "amp_code": "SAM477706-00",
  "strengths": [
    "60.0000",
    "60.0000",
    "16.0000",
    "16.0000",
    "30.0000",
    "30.0000",
    "70.0000",
    "70.0000"
  ],
  "pack_count": 6,
  "substances": [
    "Tolvaptan",
    "Lactose"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Tolvaptan",
  "authorisation_numbers": [
    "EU/1/15/1000/008",
    "EU/1/15/1000/010",
    "EU/1/15/1000/009",
    "EU/1/15/1000/018",
    "EU/1/15/1000/017",
    "EU/1/15/1000/019"
  ]
}

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.