Spain· ES:73938
TRANALEX 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
A medicinal product containing naltrexona, registered in Spain by Accord Healthcare S.L.U..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- naltrexona
- Manufacturer
- Accord Healthcare S.L.U.
- 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_codigo67976428EUR 22.95
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Naltrexona in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesNaltrexone HydrochlorideBryant Ranch Prepack
- CzechiaADEPENDWalter Ritter GmbH & Co.KG, HAMBURG
- FinlandNaldixPOA Pharma Scandinavia AB
- NorwayAdependOrpha-Devel Handels und Vertriebs GmbH
- PolandAdependWalter Ritter GmbH + Co. KG
- SwedenNaltrexon Molteni 50 mg Filmdragerad tablettL Molteni & C Dei F.LLI Alitti Societa di Esercizio SpA
- IrelandEthylex 50 mg film-coated tabletsWalter Ritter GmbH & Co. KG
- NetherlandsNaltrexon HCl Walter Ritter 50 mg filmomhulde tablettenWalter Ritter GmbH & Co. KG
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Dependex, Ethylex
- Belgium · Naltrexone Accord
- Cyprus · Abernil
- Czechia · Adepend, Naltrexone Walter Ritter
- Germany · Adepend, Naltrexon-Hcl Neuraxpharm
- Denmark · Naltrexon "walter Ritter", Naltrexon Accord
- Estonia · Naltrexone Accord
- Finland · Naldix, Naltrexon Accord
- France · Naltrexone Accord, Naltrexone Viatris
- United Kingdom (Northern Ireland) · Adepend, Naltrexone Hydrochloride Accord Healthcare
- Croatia · Adepend, Naltreksonklorid Walter Ritter
- Hungary · Adepend
- Ireland · Ethylex, Naltrexone Hydrochloride Accord Healthcare Ireland
- Italy · Antaxone, Nalorex
- Lithuania · Naltrexone Accord
- Latvia · Naltrexone Accord
- Netherlands · Naltrexon Hcl Walter Ritter, Naltrexon Hydrochloride Accord
- Norway · Naltrexone Accord, Naltrexone Poa Pharma
- Poland · Adepend, Naltex
- Portugal · Destoxican, Naltrexona Accord
- Romania · Naltrexona Amomed, Naltrexona Walter Ritter
- Sweden · Naltrexon Molteni, Naltrexon Vitaflo
- Slovenia · Adepend, Naltrekson Walter Ritter
- Slovakia · Adepend
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/865d530e-409c-4683-a7c4-a90c3bb7e247 GET /v1/drugs/865d530e-409c-4683-a7c4-a90c3bb7e247?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\":1303682400000}",
"nregistro": "73938",
"substance": "naltrexona"
}See everything about naltrexona.
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.