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Spain· ES:65372

FENITOINA ALTAN 50 MG/ ML SOLUCION INYECTABLE

A medicinal product containing fenitoína, registered in Spain by Altan Pharmaceuticals S.A..

Checked against AEMPS CIMA (Spain) on

Informational only — not a medical device.

SOURCE REGISTER · ESAEMPS CIMA (Spain)normalisedFENITOINA ALTAN 50 MG/ ML SOLUCION IN…ATC—REGISTER NO.ES:65372PACKS LISTED0CHECKEDSeptember 12, 2026

The record

At a glance

AEMPS CIMA (Spain)
Active substance
fenitoína
Manufacturer
Altan Pharmaceuticals 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.

All fenitoína products

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/2bc3a8f7-3b38-457a-873c-60464a45bc25
GET /v1/drugs/2bc3a8f7-3b38-457a-873c-60464a45bc25?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\":1053986400000}",
  "nregistro": "65372",
  "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.