Belgium· BE-AMP-SAM564711-00
Sarclisa 20 mg/ml
A isatuximab product containing isatuximab, registered in Belgium by Sanofi Winthrop Industrie. The same ATC class is registered in 12 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Isatuximab is registered in 12 of 19 countries.
Countries holding a registration under ATC L01FC02 (isatuximab), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 8 of them publish a price we can compare per daily dose
Isatuximab · ATC L01FC02
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Isatuximab
- Manufacturer
- Sanofi Winthrop Industrie
- Country
- Belgium (BE)
- ATC code
- L01FC02
- ATC class
- Isatuximab
- Defined daily dose
- 50 mg, P
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 2
- be_apb4225587
- be_apb7734122
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
113 interactions on record for isatuximab.
Graded by severity as the source publishes them — 28 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Isatuximab · interactions on record
113 records
- 28 severe
- 85 moderate
Most severe, free to view
- CladribineL01BB04severe
- Talimogene laherparepvecL01XL02severe
- Talimogen laherparepvecL01XX51severe
- LeflunomidL04AA13severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
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
- FinlandSarclisaSanofi Winthrop Industrie
- NorwaySarclisaSanofi Winthrop Industrie
- PolandSarclisaSanofi Winthrop Industrie
- SwedenSARCLISA 20 mg/ml Koncentrat till infusionsvätska, lösningSanofi Winthrop Industrie
- IcelandSarclisaSanofi Winthrop Industrie
- SwitzerlandSarclisa 100 mg/5 mL , solution à diluer pour perfusionSanofi-Aventis (Suisse) SA
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 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/5fe5f5b0-3e1a-402d-a63f-1c68b4cac4be GET /v1/drugs/5fe5f5b0-3e1a-402d-a63f-1c68b4cac4be?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": "Concentrate for solution for infusion",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Sarclisa 20 mg/ml",
"name_fr": "Sarclisa 20 mg/ml",
"name_nl": "Sarclisa 20 mg/ml",
"amp_code": "SAM564711-00",
"strengths": [
"20.0000",
"20.0000",
"1.0000"
],
"pack_count": 2,
"substances": [
"Isatuximab",
"Sucrose",
"Polysorbate 80"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Isatuximab",
"authorisation_numbers": [
"EU/1/20/1435/001",
"EU/1/20/1435/002"
]
}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.