Spain· ES:56245
FENITOINA RUBIO 50 MG/ML SOLUCIÓN INYECTABLE
A medicinal product containing fenitoína, registered in Spain by Laboratorios Rubio S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- fenitoína
- Manufacturer
- Laboratorios Rubio 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 · 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
Fenitoína in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaEPANUTIN PARENTERALUpjohn EESV, Capelle aan den IJssel
- NorwayPhenhydanDesitin
- PolandEpanutin ParenteralViatris Healthcare Limited
- FinlandEpanutinWarner Lambert Nordic AB
- NetherlandsEpanutin ready mixed, injectievloeistof 250 mg/5mlViatris Healthcare Limited
- United KingdomDilantin Infatabs 50mg chewable tabletsImported (Canada)
- United StatesDILANTINViatris Specialty LLC
- IrelandEpanutin 100 mg Hard CapsulesUpjohn EESV
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Austria · Epanutin, Epilan-D
- Belgium · Diphantoïne
- Cyprus · Epanutin, Fenitoína Rubió
- Czechia · Epanutin Parenteral, Epilan D
- Germany · Phenhydan, Phenytoin Awd
- Estonia · Phenhydan
- Finland · Hydantin
- France · Di-Hydan, Dilantin
- United Kingdom (Northern Ireland) · Epanutin, Epanutin Infatabs
- Greece · Epanutin
- Hungary · Diphedan, Epanutin
- Ireland · Epanutin, Epanutin Infatabs
- Italy · Aurantin, Dintoina
- Luxembourg · Diphantoïne
- Malta · Epanutin, Epanutin Ready Mixed Parenteral
- Netherlands · Diphantoine-Z 100, Diphantoïne-Z 100
- Poland · Epanutin Parenteral, Phenytoin Hikma
- Portugal · Fenitan, Fenitoína Accord
- Romania · Fenitoină Richter, Phenhydan
- Sweden · Epanutin
- Slovakia · Epilan D
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/329f4c72-cd63-47c8-adcc-3c60995f6854 GET /v1/drugs/329f4c72-cd63-47c8-adcc-3c60995f6854?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": "Uso Hospitalario",
"estado": "{\"aut\":457480800000}",
"nregistro": "56245",
"substance": "fenitoína"
}See everything about fenitoína.
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.