Spain· ES:45695
EPANUTIN 100 mg CAPSULAS DURAS
A medicinal product containing fenitoína, registered in Spain by Viatris Healthcare Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- fenitoína
- Manufacturer
- Viatris Healthcare Limited
- 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_codigo750976100EUR 3.12
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.
- United KingdomEpanutin 100mg capsulesWaymade Healthcare Plc
- United StatesExtended Phenytoin SodiumAmneal Pharmaceuticals LLC
- IrelandEpanutin 100 mg Hard CapsulesViatris Healthcare Limited
- CanadaDILANTINBGP PHARMA ULC
- BelgiumEpanutin 100 mgPfizer
- NorwayEpanutinPfizer
- SwedenEpanutin 100 mg Kapsel, hårdViatris AB
- NetherlandsDiphantoine-Z 100, tabletten 92 mgAurobindo Pharma B.V.
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/66511107-55b4-426d-8ff4-e9cf50e5ebc0 GET /v1/drugs/66511107-55b4-426d-8ff4-e9cf50e5ebc0?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\":-57978000000}",
"nregistro": "45695",
"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.