Netherlands· NL-e944f1e52cb8
Scemblix 40mg, filmomhulde tablet
A bcr-abl tyrosine kinase inhibitors product containing asciminibhydrochloride, registered in Netherlands by Novartis Europharm Limited.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
The record
At a glance
CBG-MEB (Netherlands)- Active substance
- ASCIMINIBHYDROCHLORIDE
- Manufacturer
- Novartis Europharm Limited
- Country
- Netherlands (NL)
- ATC code
- L01EA
- ATC class
- BCR-ABL tyrosine kinase inhibitors
- Reimbursed
- Not published by this register
- Source register
- CBG-MEB (Netherlands)
- Last checked
- September 29, 2026
Packs & prices · 1
- cbg_meb_idEU/1/22/1670
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Asciminibhydrochloride in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaSCEMBLIXNovartis Europharm Limited, Dublin
- SwitzerlandScemblix 40 mg, FilmtablettenNovartis Pharma Schweiz AG
- SpainSCEMBLIX 40 MG COMPRIMIDOS RECUBIERTOS CON PELICULANovartis Europharm Limited
- FinlandScemblixNovartis Europharm Limited
- FranceSCEMBLIX 40 mg, comprimés pelliculésNOVARTIS EUROPHARM (IRLANDE)
- IrelandScemblix 40 mg film-coated tabletsNovartis Europharm Limited
- IcelandScemblixNovartis Europharm Limited*
- NorwayScemblixNovartis Europharm Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Scemblix
- Liechtenstein · Scemblix
- Norway · Scemblix
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/d379358e-1910-4553-96ec-657782493606 GET /v1/drugs/d379358e-1910-4553-96ec-657782493606?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": "Filmomhulde tablet",
"route": "Oraal gebruik",
"soort": null,
"source": "cbg_meb",
"smpc_url": "https://www.ema.europa.eu/en/documents/product-information/scemblix-epar-product-information_nl.pdf",
"strength": null,
"atc_label": "BCR-ABL tyrosine kinase inhibitors",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp128576",
"excipients": [
"CELLULOSE, MICROKRISTALLIJN (E 460(i))",
"CROSCARMELLOSE NATRIUM (E 468)",
"HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a)",
"IJZEROXIDE ROOD (E 172)",
"IJZEROXIDE ZWART (E 172)",
"LACTOSE 1-WATER",
"LECITHINE, SOYA (E 322)",
"MAGNESIUMSTEARAAT (E 470b)",
"POLYVINYLALCOHOL (E 1203)",
"SILICIUMDIOXIDE (E 551)",
"TALK (E 553b)",
"TITAANDIOXIDE (E 171)",
"XANTHAANGOM (E 415)"
],
"substances": [
"ASCIMINIBHYDROCHLORIDE"
],
"leaflet_url": null,
"authorised_at": "2022/08/25",
"procedure_number": "EMEA/H/C/005605",
"dispensing_status": "Uitsluitend recept",
"registration_number": "EU/1/22/1670",
"additional_monitoring": "Y"
}See everything about asciminibhydrochloride.
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.