France· FR:66347126
SEPHIENCE 250 mg, poudre orale en sachet
A sepiapterin product containing sépiaptérine, registered in France by PTC THERAPEUTICS INTERNATIONAL (IRLANDE). The same ATC class is registered in 9 of our 19 countries.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
Where it is registered
Sepiapterin is registered in 9 of 19 countries.
Countries holding a registration under ATC A16AX28 (sepiapterin), each read from that country’s own register.
- This record: France, from Base de données publique des médicaments — BDPM (France)
- 5 of them publish a price we can compare per daily dose
Sepiapterin · ATC A16AX28
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Franceprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- United Statesprice
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- SÉPIAPTÉRINE
- Manufacturer
- PTC THERAPEUTICS INTERNATIONAL (IRLANDE)
- Country
- France (FR)
- ATC code
- A16AX28
- ATC class
- Sepiapterin
- Defined daily dose
- 4.25 g, O
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip13340093031888130 sachet(s) polytéréphtalate (PET) PE-aluminium polyéthylène
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sepiapterin in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesSephienceallphamed Pharbil Arzneimittel GmbH
- SwitzerlandSephience 250 mg, Pulver zum EinnehmenPTC Therapeutics Switzerland GmbH
- CzechiaSEPHIENCEPTC Therapeutics International Limited, Dublin 2
- SpainSEPHIENCE 250 MG POLVO ORAL EN SOBREPtc Therapeutics International Limited
- FinlandSephiencePTC Therapeutics International Limited
- BelgiumSephience 250 mgPTC Therapeutics International
- IcelandSephiencePTC Therapeutics International Limited
- NetherlandsSephience 250 mg poeder voor oraal gebruik in sachetPTC Therapeutics International Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Sephience
- Liechtenstein · Sephience
- Norway · Sephience
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/4d9a3af4-cdcc-492c-bc7e-d13b4a6cf059 GET /v1/drugs/4d9a3af4-cdcc-492c-bc7e-d13b4a6cf059?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": "66347126",
"date_amm": "2025-06-19",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/25/1939",
"substance": "SÉPIAPTÉRINE",
"atc_source": "fr_atc_restore_2026-09-06",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "poudre",
"voies_administration": "orale",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Oui"
}See everything about sepiapterin.
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.