Spain· ES:57257
SERC 8 mg/ml SOLUCION ORAL
A medicinal product containing betahistina, registered in Spain by Neuraxpharm Spain S.L..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- betahistina
- Manufacturer
- Neuraxpharm Spain S.L.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- June 3, 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
Betahistina in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaBETAHISTIN ACCORDACCORD HEALTHCARE POLSKA Sp. z o.o., Varšava
- PolandApoBetinaAurovitas Pharma Polska Sp. z o.o.
- United KingdomBetahistine 16mg tabletsMawdsley-Brooks & Company Ltd
- NetherlandsBetahistine 2 HCl Accord 16 mg tablettenAccord Healthcare B.V.
- FinlandAcuverCyathus Exquirere Pharmaforschungs GmbH
- FranceBETAHISTINE ACCORD 24 mg, comprimé sécableACCORD HEALTHCARE FRANCE
- BelgiumBetahistine Apotex 16 mgApotex
- CanadaAURO-BETAHISTINEAURO PHARMA INC
Authorised across Europe · EMA
The same active substance is authorised in 28 EEA countries. Names it is sold under:
- Austria · Betahistin Accord, Betahistin Ratiopharm
- Belgium · Betahistine Eg, Betahistine Eurogenerics
- Bulgaria · Бетасерк, Бетастад
- Cyprus · Alfinor, Antivom
- Czechia · Betahistin Accord, Betahistin Actavis
- Germany · Betahistin Al, Betahistin Ratiopharm
- Denmark · Betahistin 2care4, Betahistin Orifarm Generics
- Estonia · Betahistine Accord, Betahistine Actavis
- Finland · Betahistin Mylan, Betahistin Orifarm Generics
- France · Betahistine, Betahistine Accord
- United Kingdom (Northern Ireland) · Betahistine, Betahistine Dihydrochloride
- Greece · Antivom, Betaserc
- Croatia · Betaserc, Urutal
- Hungary · Betagen, Betahistin Ratiopharm
- Ireland · Betahistine Dihydrochloride Accord Healthcare Ireland, Betahistine Dihydrochloride Azure Pharmaceuticals
- Iceland · Menisy
- Italy · Averbet, Betaistina Accord
- Lithuania · Betahistine Accord, Betahistine Actavis
- Luxembourg · Betahistine Eurogenerics, Betahistine Viatris
- Latvia · Betahistine Accord, Betahistine Actavis
- Malta · Betahistine Aurobindo Pharma (Malta), Betaserc
- Netherlands · Betahistine 2hcl Accord, Betahistine 2hcl Adoh
- Poland · Apobetina, Aurobetina
- Portugal · Beta-Histina Aurobindo, Beta-Histina Aurovitas
- Romania · Betahistină Atb, Betahistină Gemax Pharma
- Sweden · Betahistin 2care4, Betahistine Stada
- Slovenia · Betahistin Accord, Betaserc
- Slovakia · Betahistin Actavis, Betahistin Viatris
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/c39787f7-7925-4b82-a8fd-1a254ddc8747 GET /v1/drugs/c39787f7-7925-4b82-a8fd-1a254ddc8747?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\":552088800000,\"rev\":1727783726000}",
"nregistro": "57257",
"substance": "betahistina"
}See everything about betahistina.
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.