Germany· DE-A57-aae7ac647312286c
Tolvaptan Ascend
A medicinal product containing tolvaptan, registered in Germany by Ascend Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Tolvaptan
- Manufacturer
- Ascend Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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.
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
- 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 EMA Article 57 (European Union). 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/49702ec4-c68e-4a6b-84e0-3ec52f72f4d4 GET /v1/drugs/49702ec4-c68e-4a6b-84e0-3ec52f72f4d4?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.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Tolvaptan",
"atc_from_source": null,
"authorisation_country": "Germany"
}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.