Netherlands· NL-2537fe739288
Itovebi 3 mg filmomhulde tabletten
A phosphatidylinositol-3-kinase (pi3k) inhibitors product containing inavolisib, registered in Netherlands by Roche Registration GmbH.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
The record
At a glance
CBG-MEB (Netherlands)- Active substance
- INAVOLISIB
- Manufacturer
- Roche Registration GmbH
- Country
- Netherlands (NL)
- ATC code
- L01EM
- ATC class
- Phosphatidylinositol-3-kinase (Pi3K) inhibitors
- Reimbursed
- Not published by this register
- Source register
- CBG-MEB (Netherlands)
- Last checked
- September 29, 2026
Packs & prices · 1
- cbg_meb_idEU/1/25/1942
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Inavolisib in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumItovebi 3 mgRoche Registration
- SwitzerlandItovebi 3 mg, FilmtablettenRoche Pharma (Schweiz) AG
- CzechiaITOVEBIRoche Registration GmbH, Grenzach-Wyhlen
- SpainITOVEBI 3 MG COMPRIMIDOS RECUBIERTOS CON PELICULARoche Registration Gmbh
- FinlandItovebiRoche Registration GmbH
- FranceITOVEBI 3 mg, comprimé pelliculéROCHE REGISTRATION (ALLEMAGNE)
- IrelandItovebi 3 mg film-coated tabletsRoche Registration GmbH
- IcelandItovebiRoche Registration GmbH*
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Itovebi
- Liechtenstein · Itovebi
- Norway · Itovebi
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/e8d62d3f-d16b-46f9-a014-1007602b44be GET /v1/drugs/e8d62d3f-d16b-46f9-a014-1007602b44be?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/itovebi-epar-product-information_nl.pdf",
"strength": null,
"atc_label": "Phosphatidylinositol-3-kinase (Pi3K) inhibitors",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp133517",
"excipients": [
"CELLULOSE, MICROKRISTALLIJN (E 460(i))",
"IJZEROXIDE ROOD (E 172)",
"LACTOSE 1-WATER",
"MACROGOL 3350",
"MAGNESIUMSTEARAAT (E 470b)",
"NATRIUMZETMEELGLYCOLAAT",
"POLYVINYLALCOHOL (E 1203)",
"TALK (E 553b)",
"TITAANDIOXIDE (E 171)"
],
"substances": [
"INAVOLISIB"
],
"leaflet_url": null,
"authorised_at": "2025/07/18",
"procedure_number": "EMEA/H/C/006353",
"dispensing_status": "Uitsluitend recept",
"registration_number": "EU/1/25/1942",
"additional_monitoring": "Y"
}See everything about inavolisib.
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.