Iceland· IS-EU/1/25/1939/001
Sephience
A sepiapterin product containing sepiapterin, registered in Iceland by PTC Therapeutics International Limited. The same ATC class is registered in 9 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Sepiapterin
- Manufacturer
- PTC Therapeutics International Limited
- Country
- Iceland (IS)
- ATC code
- A16AX28
- ATC class
- Sepiapterin
- Defined daily dose
- 4.25 g, O
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 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.
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
- IrelandSephience 250 mg oral powder in sachetPTC 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 2 EEA countries. Names it is sold under:
- 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 Icelandic Medicines Agency (Iceland). 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/9cef4d6e-7a85-45d8-9ade-4205efe95a59 GET /v1/drugs/9cef4d6e-7a85-45d8-9ade-4205efe95a59?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": "Duft til inntöku í skammtapoka",
"source": "lyfjastofnun",
"atc_raw": "A16AX28",
"marketed": false,
"strength": "250 mg",
"ma_number": "EU/1/25/1939/001",
"substance": "Sepiapterin",
"other_info": "Ávísun lyfsins er bundin við sérfræðinga í efnaskipta- og innkirtlasjúkdómum og sérfræðinga í nýrnasjúkdómum.",
"legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
"ma_issued_serial": "45827"
}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.