France· FR:60771794
PRODILANTIN 75 mg/mL, solution à diluer pour perfusion/solution injectable
A medicinal product containing fosphénytoïne sodique heptahydraté, registered in France by PFIZER HOLDING FRANCE.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- FOSPHÉNYTOÏNE SODIQUE HEPTAHYDRATÉ
- Manufacturer
- PFIZER HOLDING FRANCE
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip13340095610950010 flacon(s) en verre de 10 ml
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Fosphénytoïne sodique heptahydraté in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesCEREBYXPfizer Laboratories Div Pfizer Inc
- SwedenFosphenytoin Eugia 75 mg/ml (50 mg FE/ml) Koncentrat till injektions-/infusionsvätska, lösningEugia Pharma (Malta) Limited
- GermanyFosphenytoin DesitinDesitin Arzneimittel Gmbh
- CanadaCEREBYXSEARCHLIGHT PHARMA INC
- IcelandPro-EpanutinPfizer ApS
- NorwayPro-EpanutinPfizer AS
- IrelandPro-Epanutin 75 mg/ml concentrate for solution for infusion/solution for injectionPfizer Healthcare Ireland Unlimited Company
- FinlandPro-EpanutinPfizer Oy
Authorised across Europe · EMA
The same active substance is authorised in 8 EEA countries. Names it is sold under:
- Germany · Fosphenytoin Desitin
- Denmark · Pro-Epanutin
- Finland · Pro-Epanutin
- United Kingdom (Northern Ireland) · Pro-Epanutin
- Ireland · Pro-Epanutin
- Iceland · Pro-Epanutin
- Norway · Pro-Epanutin
- Sweden · Fosphenytoin Eugia, Fosphenytoin Frost
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 Base de données publique des médicaments — BDPM (France). 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/ff84860e-c333-485d-b7ec-7e4a5b85aaea GET /v1/drugs/ff84860e-c333-485d-b7ec-7e4a5b85aaea?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.
{
"cis": "60771794",
"date_amm": "1998-08-06",
"type_amm": "Procédure de reconnaissance mutuelle",
"numero_ue": null,
"substance": "FOSPHÉNYTOÏNE SODIQUE HEPTAHYDRATÉ",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "solution à diluer pour solution injectable ou pour perfusion",
"voies_administration": "intramusculaire;intraveineuse",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about fosphénytoïne sodique heptahydraté.
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.