Belgium· BE-AMP-SAM463075-00
Translarna 1000 mg
A ataluren product containing ataluren, registered in Belgium by PTC Therapeutics. The same ATC class is registered in 6 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Ataluren is registered in 6 of 19 countries.
Countries holding a registration under ATC M09AX03 (ataluren), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 4 of them publish a price we can compare per daily dose
Ataluren · ATC M09AX03
6 / 19 countries
- Belgiumprice
- Finlandprice
- Franceprice
- Ireland
- Polandprice
- United Kingdom
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Ataluren
- Manufacturer
- PTC Therapeutics
- Country
- Belgium (BE)
- ATC code
- M09AX03
- ATC class
- Ataluren
- Defined daily dose
- 2.8 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
Ataluren in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- PolandTranslarnaPTC Therapeutics International Limited
- FranceTRANSLARNA 1000 mg, granulés pour suspension buvablePTC THERAPEUTICS INTERNATIONAL (IRLANDE)
- SpainTRANSLARNA 1000 MG GRANULADO PARA SUSPENSION ORALPtc Therapeutics International Limited
- FinlandTranslarnaPTC Therapeutics International Limited
- United KingdomTranslarna 1,000mg granules for oral suspension sachetsPTC Therapeutics Ltd
- IrelandTranslarnaPTC Therapeutics International Limited
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/6e74df55-6e87-41ea-9b5d-033ccfb1a6e0 GET /v1/drugs/6e74df55-6e87-41ea-9b5d-033ccfb1a6e0?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": "Granules for oral suspension",
"source": "afmps",
"status": "REVOKED",
"name_en": "Translarna 1000 mg",
"name_fr": "Translarna 1000 mg",
"name_nl": "Translarna 1000 mg",
"amp_code": "SAM463075-00",
"strengths": [
"1000.0000",
"1000.0000"
],
"pack_count": 1,
"substances": [
"Ataluren",
"Mannitol"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Ataluren",
"authorisation_numbers": [
"EU/1/13/902/003"
]
}See everything about ataluren.
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.