France· FR:62519799
SOTALEX 80 mg, comprimé sécable
A medicinal product containing sotalol (chlorhydrate de), registered in France by CHEPLAPHARM ARZNEIMITTEL (ALLEMAGNE), on the national reimbursement list.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- SOTALOL (CHLORHYDRATE DE)
- Manufacturer
- CHEPLAPHARM ARZNEIMITTEL (ALLEMAGNE)
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- Yes
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cip133400931815808plaquette(s) PVC-Aluminium de 30 comprimé(s)EUR 2.43
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sotalol (chlorhydrate de) in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesBETAPACELegacy Pharma USA, Inc.
- United KingdomBeta-Cardone 80mg tabletsFocus Pharmaceuticals Ltd
- FinlandSotacorCheplapharm Arzneimittel GmbH
- ItalyRYTMOBETAVIATRIS ITALIA S.R.L.
- NetherlandsSotalol HCl 80 mg Focus, tablettenFocus Care Pharmaceuticals B.V.
- CzechiaSOTAHEXALHexal AG, Holzkirchen
- PolandBiosotal 80CHEPLAPHARM Arzneimittel GmbH
- CanadaAPO-SOTALOLAPOTEX INC
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Austria · Sotahexal, Sotastad
- Belgium · Sotalex, Sotalol Sandoz
- Bulgaria · Дароб, Сотагамма, Sotagamma
- Cyprus · Sotalol Mc, Sotax
- Czechia · Sotahexal
- Germany · Darob Mite, Sotahexal
- Denmark · Sotalol Viatris
- Estonia · Sotahexal
- Spain · Sotalol Sandoz, Sotapor
- Finland · Sotacor, Sotalol Viatris
- United Kingdom (Northern Ireland) · Beta-Cardone, Sotalol Bristol Laboratories
- Greece · Sotalol Mylan
- Croatia · Darob Mite
- Hungary · Sotalex Mite
- Ireland · Sotoger
- Iceland · Sotalol Viatris
- Italy · Rytmobeta, Sotalex
- Luxembourg · Sotalex
- Latvia · Sotagamma
- Malta · Sotalol Hydrochloride Accord Healthcare
- Netherlands · Sotalol Hcl Focus, Sotalol Hcl Hyloris
- Norway · Sotalol Mylan
- Poland · Biosotal 40, Biosotal 80
- Portugal · Darob, Sotalol Aurobindo
- Romania · Darob, Sotagamma
- Sweden · Sotacor, Sotalol Viatris
- Slovenia · Darob Mite
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 Base de données publique des médicaments — BDPM (France). 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/30344285-a9a4-4846-8bab-458aebef3aa3 GET /v1/drugs/30344285-a9a4-4846-8bab-458aebef3aa3?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.
{
"cis": "62519799",
"date_amm": "1991-02-15",
"type_amm": "Procédure nationale",
"numero_ue": null,
"substance": "SOTALOL (CHLORHYDRATE DE)",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "comprimé sécable",
"voies_administration": "orale",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about sotalol (chlorhydrate de).
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.