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Netherlands· NL-020405f46d0d

Sephience 250 mg poeder voor oraal gebruik in sachet

A sepiapterin product containing sepiapterin, registered in Netherlands by PTC Therapeutics International Limited. The same ATC class is registered in 9 of our 19 countries.

ATC A16AX28

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedSephience 250 mg poeder voor oraal ge…ATCA16AX28REGISTER NO.NL-020405f46d0dPACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about sepiapterinAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Netherlands, from CBG-MEB (Netherlands)
  • 5 of them publish a price we can compare per daily dose
Search sepiapterin products by name

Sepiapterin · ATC A16AX28

9 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Franceprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • 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

CBG-MEB (Netherlands)
Active substance
SEPIAPTERIN
Manufacturer
PTC Therapeutics International Limited
Country
Netherlands (NL)
ATC code
A16AX28
ATC class
Sepiapterin
Defined daily dose
4.25 g, O
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/25/1939

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.

All sepiapterin products

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 CBG-MEB (Netherlands). 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/e0666c8b-bfc6-43e1-a75b-41c0a667f65e
GET /v1/drugs/e0666c8b-bfc6-43e1-a75b-41c0a667f65e?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": "Poeder voor oraal gebruik",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/sephience-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Sepiapterin",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp133337",
  "excipients": [
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "CROSCARMELLOSE  NATRIUM  (E 468)",
    "ISOMALT (E 953)",
    "MAGNESIUMSTEARAAT (E 470b)",
    "MANNITOL (D-) (E 421)",
    "SILICIUMDIOXIDE (E 551)",
    "SUCRALOSE (E 955)",
    "XANTHAANGOM (E 415)"
  ],
  "substances": [
    "SEPIAPTERIN"
  ],
  "leaflet_url": null,
  "authorised_at": "2025/06/19",
  "procedure_number": "EMEA/H/C/006331",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/25/1939",
  "additional_monitoring": "Y"
}
API referenceMCP serverPlans

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.

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