Netherlands· NL-3d153f95eb5a
Kesimpta 20 mg, oplossing voor injectie in voorgevulde pen
A ofatumumab product containing ofatumumab, registered in Netherlands by Novartis Europharm Limited. The same ATC class is registered in 10 of our 19 countries.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
Where it is registered
Ofatumumab is registered in 10 of 19 countries.
Countries holding a registration under ATC L04AG12 (ofatumumab), each read from that country’s own register.
- This record: Netherlands, from CBG-MEB (Netherlands)
- 7 of them publish a price we can compare per daily dose
Ofatumumab · ATC L04AG12
10 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
CBG-MEB (Netherlands)- Active substance
- OFATUMUMAB
- Manufacturer
- Novartis Europharm Limited
- Country
- Netherlands (NL)
- ATC code
- L04AG12
- ATC class
- Ofatumumab
- Defined daily dose
- 0.67 mg, P
- Reimbursed
- Not published by this register
- Source register
- CBG-MEB (Netherlands)
- Last checked
- September 29, 2026
Packs & prices · 1
- cbg_meb_idEU/1/21/1532
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
70 interactions on record for ofatumumab.
Graded by severity as the source publishes them — 29 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
Ofatumumab · interactions on record
70 records
- 29 severe
- 41 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
Ofatumumab in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- IrelandKesimpta 20 mg solution for injection in pre-filled penNovartis Europharm Limited
- FranceKESIMPTA 20 mg, solution injectable en stylo prérempliNOVARTIS EUROPHARM (IRLANDE)
- BelgiumArzerra 100 mgNovartis Europharm
- FinlandArzerraNovartis Europharm Limited
- CzechiaKESIMPTANovartis Europharm Limited, Dublin
- United KingdomArzerra 1000mg/50ml concentrate for solution for infusion vialsNovartis Pharmaceuticals UK Ltd
- SpainKESIMPTA 20 mg SOLUCION INYECTABLE EN PLUMA PRECARGADANovartis Europharm Limited
- IcelandKesimptaNovartis Europharm Limited*
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Kesimpta
- Liechtenstein · Kesimpta
- Norway · Kesimpta
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/7fde637c-9a05-4e50-a744-5bcef0b57df1 GET /v1/drugs/7fde637c-9a05-4e50-a744-5bcef0b57df1?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": "Oplossing voor injectie",
"route": "Subcutaan gebruik",
"soort": null,
"source": "cbg_meb",
"smpc_url": "https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_nl.pdf",
"strength": null,
"atc_label": "Ofatumumab",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp126213",
"excipients": [
"ARGININE, (L-)",
"DINATRIUMEDETAAT 2-WATER",
"NATRIUMACETAAT 3-WATER (E 262)",
"NATRIUMCHLORIDE",
"POLYSORBAAT 80 (E 433)",
"WATER VOOR INJECTIE",
"ZOUTZUUR (E 507)"
],
"substances": [
"OFATUMUMAB"
],
"leaflet_url": null,
"authorised_at": "2020/03/26",
"procedure_number": "EMEA/H/C/005410",
"dispensing_status": "Uitsluitend recept",
"registration_number": "EU/1/21/1532",
"additional_monitoring": "N"
}See everything about ofatumumab.
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.