Spain· ES:59809
SABRILEX 500 mg GRANULADO PARA SOLUCION ORAL
A medicinal product containing vigabatrina, registered in Spain by Sanofi Aventis S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- vigabatrina
- Manufacturer
- Sanofi Aventis S.A.
- 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_codigo74363350EUR 30.13
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Vigabatrina in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandSabrilexSanofi Oy
- FranceSABRIL 500 mg, granulés pour solution buvable en sachet-doseSANOFI WINTHROP INDUSTRIE
- PolandSabrilSanofi Winthrop Industrie
- United StatesSABRILLundbeck Pharmaceuticals LLC
- United KingdomKigabeq 100mg soluble tabletsOrphalan UK Ltd
- NetherlandsKIGABEQ 100 mg, oplosbare tabletORPHELIA Pharma SA
- SwedenKIGABEQ 100 mg Löslig tablettOrphelia Pharma SAS
- IrelandKigabeq 100 mg Soluble tabletOrphelia Pharma SA
Authorised across Europe · EMA
The same active substance is authorised in 22 EEA countries. Names it is sold under:
- Austria · Sabril
- Belgium · Sabril
- Czechia · Sabril
- Germany · Sabril, Sabril Beutel
- Denmark · Sabrilex
- Finland · Sabrilex
- France · Sabril, Vigzip
- United Kingdom (Northern Ireland) · Sabril, Vigabatrin Zydus Pharmaceuticals Uk
- Greece · Sabril
- Hungary · Sabril
- Ireland · Sabril
- Iceland · Kigabeq, Sabrilex
- Italy · Sabril, Vigzip
- Liechtenstein · Kigabeq
- Luxembourg · Sabril
- Netherlands · Sabril, Sabril Filmomhulde Tablet
- Norway · Kigabeq, Sabrilex
- Poland · Sabril
- Portugal · Sabril
- Sweden · Sabrilex
- Slovenia · Sabril
- Slovakia · Sabril
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/75c07a57-68e1-48b6-b396-ce407025d068 GET /v1/drugs/75c07a57-68e1-48b6-b396-ce407025d068?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. Tratamiento De Larga Duración",
"estado": "{\"aut\":738885600000}",
"nregistro": "59809",
"substance": "vigabatrina"
}See everything about vigabatrina.
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.