Sweden· SE-20230425000147
Rozlytrek 50 mg Filmdragerat granulat i dospåse
A medicinal product containing entrectinib, registered in Sweden by Roche Registration GmbH.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Entrectinib
- Manufacturer
- Roche Registration GmbH
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20230425000147
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Entrectinib in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaENTRECTINIB
- SpainROZLYTREK 50 MG GRANULADO RECUBIERTO CON PELICULA EN SOBRERoche Registration Gmbh
- FinlandRozlytrekRoche Registration GmbH
- IrelandRozlytrek 50 mg film-coated granules in sachetRoche Registration GmbH
- NetherlandsRozlytrek 50 mg filmomhuld granulaat in sachetRoche Registration GmbH
- NorwayRozlytrekRoche Registration GmbH
- BelgiumRozlytrek 50 mgRoche Registration
- PolandRozlytrekRoche Registration GmbH
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Rozlytrek
- Liechtenstein · Rozlytrek
- Norway · Rozlytrek
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 Swedish Medical Products Agency (Sweden). 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/ada4261c-364f-49a0-92c4-23485465b445 GET /v1/drugs/ada4261c-364f-49a0-92c4-23485465b445?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.
{
"source": "lakemedelsverket",
"doc_types": [
"EPAR",
"EMA"
],
"se_npl_id": "20230425000147",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20230425000147",
"product_doc_link": "https://www.ema.europa.eu/sv/documents/product-information/rozlytrek-epar-product-information_sv.pdf"
}See everything about entrectinib.
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.