Belgium· BE-AMP-SAM664838-00
Sephience 1000 mg
A sepiapterin product containing sepiapterin, registered in Belgium by PTC Therapeutics International. The same ATC class is registered in 9 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Sepiapterin
- Manufacturer
- PTC Therapeutics International
- Country
- Belgium (BE)
- ATC code
- A16AX28
- ATC class
- Sepiapterin
- Defined daily dose
- 4.25 g, O
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 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
- CzechiaSEPHIENCEPTC Therapeutics International Limited, Dublin 2
- SpainSEPHIENCE 1000 MG POLVO ORAL EN SOBREPtc Therapeutics International Limited
- FinlandSephiencePTC Therapeutics International Limited
- SwitzerlandSephience 1000 mg, Pulver zum EinnehmenPTC Therapeutics Switzerland GmbH
- PolandSephiencePTC Therapeutics International Ltd.
- SwedenSephience 1000 mg Oralt pulver i dospåsePTC Therapeutics International Limited
- IcelandSephiencePTC 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 FAMHP / AFMPS (Belgium). 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/cecbdb83-f653-469e-a767-8d8014462a08 GET /v1/drugs/cecbdb83-f653-469e-a767-8d8014462a08?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": "Oral powder in sachet",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Sephience 1000 mg",
"name_fr": "Sephience 1000 mg",
"name_nl": "Sephience 1000 mg",
"amp_code": "SAM664838-00",
"strengths": [
"1000.0000",
"1000.0000",
"1600.0000"
],
"pack_count": 1,
"substances": [
"Sepiapterin",
"Isomalt",
"Mannitol"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Sepiapterin",
"authorisation_numbers": [
"EU/1/25/1939/002"
]
}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.