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Ireland· IE-PA-PA0822/019/001

Pro-Epanutin 75 mg/ml concentrate for solution for infusion/solution for injection

A fosphenytoin product containing fosphenytoin sodium, registered in Ireland by Pfizer Healthcare Ireland Unlimited Company. The same ATC class is registered in 11 of our 19 countries.

ATC N03AB05

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedPro-Epanutin 75 mg/ml concentrate for…ATCN03AB05REGISTER NO.IE-PA-PA0822/019/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Fosphenytoin is registered in 11 of 19 countries.

Countries holding a registration under ATC N03AB05 (fosphenytoin), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 4 of them publish a price we can compare per daily dose

Fosphenytoin · ATC N03AB05

11 / 19 countries

  • Canada
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Japan
  • Norwayprice
  • Sweden
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
Fosphenytoin sodium
Manufacturer
Pfizer Healthcare Ireland Unlimited Company
Country
Ireland (IE)
ATC code
N03AB05
ATC class
Fosphenytoin
Defined daily dose
0.45 g, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA0822/019/001

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

430 interactions on record for fosphenytoin.

Graded by severity as the source publishes them — 128 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Fosphenytoin · interactions on record

430 records

  • 128 severe
  • 275 moderate
  • 10 minor
  • 17 info

Most severe, free to view

  • CimetidineA02BA01severe
  • RolapitantA04AD14severe
  • NaloxegolA06AH03severe
  • NaldemedineA06AH05severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Fosphenytoin in 9 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All fosphenytoin products

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
  • France · Fosphenytoine Arrow, Prodilantin
  • United Kingdom (Northern 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 HPRA (Ireland). 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/4471d1ff-322a-44f9-b726-ab949a009e67
GET /v1/drugs/4471d1ff-322a-44f9-b726-ab949a009e67?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.

{
  "form": "Solution for injection/infusion",
  "routes": [
    "Intramuscular use",
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "N03AB",
    "N03AB05"
  ],
  "strength": null,
  "pa_number": "PA0822/019/001",
  "substances": [
    "Fosphenytoin sodium"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "27/07/1998",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about fosphenytoin.

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.