Spain· ES:70142
NITOMAN 25 mg COMPRIMIDOS
A medicinal product containing tetrabenazina, registered in Spain by Bausch Health Ireland Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- tetrabenazina
- Manufacturer
- Bausch Health Ireland Limited
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cima_codigo661614112EUR 123.54
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tetrabenazina in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatestetrabenazineSlate Run Pharmaceuticals, LLC
- United KingdomRevocon 25mg tabletsSun Pharmaceutical Industries Europe B.V.
- NetherlandsTetmodis 25 mg tablettenBModesto B.V.
- CanadaAPO-TETRABENAZINEAPOTEX INC
- FinlandDystardisAOP Orphan Pharmaceuticals AG
- ItalyTETRABENAZINA ARISTOARISTO PHARMA GMBH
- NorwayNitomanMediLink A/S
- SwedenTetmodis 25 mg TablettWalter Ritter GmbH+ Co. KG
Authorised across Europe · EMA
The same active substance is authorised in 25 EEA countries. Names it is sold under:
- Austria · Tetmodis, Tetrabenazin Aristo
- Belgium · Tetrabenazine Walter Ritter
- Bulgaria · Тетмодис
- Czechia · Tetmodis
- Germany · Nitoman, Tetmodis
- Denmark · Nitoman, Tetmodis
- Estonia · Tetmodis
- Finland · Tetmodis, Xenazine
- France · Tetmodis, Xenazine
- United Kingdom (Northern Ireland) · Tetrabenazine Aristo, Tetrabenazine Sun Pharmaceutical Industries Europe
- Greece · Tetmodis, Xenazine
- Croatia · Tetmodis
- Hungary · Motetis
- Ireland · Nitoman, Tetrabenazine Walter Ritter
- Italy · Tetrabenazina Aristo, Tetrabenazina Sun
- Lithuania · Tetmodis
- Latvia · Tetmodis
- Netherlands · Tetmodis, Tetrabenazine Sun
- Norway · Tetmodis
- Poland · Tetmodis
- Portugal · Nitoman, Tetmodis
- Romania · Tetmodis
- Sweden · Tetmodis, Xenazine
- Slovenia · Tetmodis, Xenazine
- Slovakia · Tetmodis
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 AEMPS CIMA (Spain). 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/b0eb630d-0cea-426d-9e44-2bde150861f4 GET /v1/drugs/b0eb630d-0cea-426d-9e44-2bde150861f4?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.
{
"cpresc": "Medicamento Sujeto A Prescripción Médica",
"estado": "{\"aut\":1223848800000}",
"nregistro": "70142",
"substance": "tetrabenazina"
}See everything about tetrabenazina.
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.