Germany· DE-A57-e46438fe8ba6fe84
Phenytoin Hikma
A phenytoin product containing phenytoin sodium, registered in Germany by Hikma Farmacêutica (Portugal), S.A.. The same ATC class is registered in 15 of our 19 countries.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
Where it is registered
Phenytoin is registered in 15 of 19 countries.
Countries holding a registration under ATC N03AB02 (phenytoin), each read from that country’s own register.
- This record: Germany, from EMA Article 57 (European Union)
- 9 of them publish a price we can compare per daily dose
Phenytoin · ATC N03AB02
15 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Finlandprice
- Franceprice
- Germany
- Ireland
- Italyprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of phenytoin costs, country by country.
Normalised to the WHO defined daily dose (0.3 g), the median price runs from $0.21 in Italy to $0.63 in France — a ×3.0 gap.
- 4 markets with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
- US figures are pharmacy acquisition cost (CMS NADAC), not retail
Phenytoin · price per daily dose (0.3 g)
USD · FX 28 Sept 2026
- FR France$0.63
- CH Switzerland$0.49
- US United States$0.44 (acquisition cost)
- IT Italy$0.21
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Phenytoin Sodium
- Manufacturer
- Hikma Farmacêutica (Portugal), S.A.
- Country
- Germany (DE)
- ATC code
- N03AB02
- ATC class
- Phenytoin
- Defined daily dose
- 0.3 g, O
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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.
Interactions
635 interactions on record for phenytoin.
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
Phenytoin · interactions on record
635 records
- 128 severe
- 332 moderate
- 13 minor
- 82 info
Most severe, free to view
- CimetidineA02BA01severe
- RolapitantA04AD14severe
- NaloxegolA06AH03severe
- NaldemedineA06AH05severe
80 more interactions with mechanism and management, from a commercially licensed source.
Sign in to check- 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.
Same medicine, other countries
Phenytoin in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomDilantin Infatabs 50mg chewable tabletsImported (Canada)
- United StatesDILANTINViatris Specialty LLC
- IrelandEpanutin 100 mg Hard CapsulesUpjohn EESV
- CanadaDILANTINBGP PHARMA ULC
- NorwayEpanutinPfizer
- NetherlandsDiphantoine-Z 100, tabletten 92 mgAurobindo Pharma B.V.
- Japanフェニトイン住友ファーマ
- SpainEPANUTIN 100 mg CAPSULAS DURASViatris Healthcare Limited
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
- Estonia · Phenhydan
- Spain · Epanutin, Fenitoína Altan Pharmaceuticals, S.A.
- 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 EMA Article 57 (European Union). 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/e2e5c3b3-5ac6-4a29-833e-f8e4788eada5 GET /v1/drugs/e2e5c3b3-5ac6-4a29-833e-f8e4788eada5?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.
{
"pzn": null,
"route": "Intravenous Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Phenytoin Sodium",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about phenytoin.
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.