Sweden· SE-20190502000067
SARCLISA 20 mg/ml Koncentrat till infusionsvätska, lösning
A medicinal product containing isatuximab, registered in Sweden by Sanofi Winthrop Industrie.
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
- Isatuximab
- Manufacturer
- Sanofi Winthrop Industrie
- 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_varunummer20190502000067
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Isatuximab in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesSarclisaSanofi-Aventis U.S. LLC
- CzechiaSARCLISASanofi Winthrop Industrie, Gentilly
- BelgiumSarclisa 20 mg/mlSanofi Winthrop Industrie
- FinlandSarclisaSanofi Winthrop Industrie
- IrelandSARCLISA 20 mg/mL concentrate for solution for infusionSanofi Winthrop Industrie
- IcelandSarclisaSanofi Winthrop Industrie
- NorwaySarclisaSanofi Winthrop Industrie
- PolandSarclisaSanofi Winthrop Industrie
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Sarclisa
- Liechtenstein · Sarclisa
- Norway · Sarclisa
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/a63deefc-6461-4049-9809-0ccb18abdcaf GET /v1/drugs/a63deefc-6461-4049-9809-0ccb18abdcaf?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": "20190502000067",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20190502000067",
"product_doc_link": "https://www.ema.europa.eu/sv/documents/product-information/sarclisa-epar-product-information_sv.pdf"
}See everything about isatuximab.
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.