Czechia· CZ-0250538
KESIMPTA
A ofatumumab product containing ofatumumab, registered in Czechia by Novartis Europharm Limited, Dublin. The same ATC class is registered in 10 of our 19 countries.
Checked against SÚKL (Czech Republic) 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: Czechia, from SÚKL (Czech Republic)
- 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
SÚKL (Czech Republic)- Active substance
- OFATUMUMAB
- Manufacturer
- Novartis Europharm Limited, Dublin
- Country
- Czechia (CZ)
- ATC code
- L04AG12
- ATC class
- Ofatumumab
- Defined daily dose
- 0.67 mg, P
- Reimbursed
- Not published by this register
- Source register
- SÚKL (Czech Republic)
- Last checked
- September 28, 2026
Packs & prices · 0
No packs listed by the register for this record.
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.
- SpainKESIMPTA 20 mg SOLUCION INYECTABLE EN PLUMA PRECARGADANovartis Europharm Limited
- BelgiumKesimpta 20 mgNovartis Europharm
- IcelandKesimptaNovartis Europharm Limited*
- SwedenKesimpta 20 mg Injektionsvätska, lösning i förfylld injektionspennaNovartis Europharm Limited
- PolandKesimptaNovartis Ireland Ltd
- NorwayKesimptaNovartis Europharm Limited
- FinlandArzerraNovartis Europharm Limited
- United KingdomArzerra 1000mg/50ml concentrate for solution for infusion vialsNovartis Pharmaceuticals UK Ltd
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 SÚKL (Czech Republic). 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/123014d4-c445-4d05-96e9-5fd0fea32fc1 GET /v1/drugs/123014d4-c445-4d05-96e9-5fd0fea32fc1?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": "INJ SOL PEP",
"source": "sukl",
"strength": "20MG",
"pack_size": "3(3X1)X0,4ML",
"substance": "OFATUMUMAB",
"cz_kod_sukl": "0250538",
"product_type": "BT",
"substance_codes": "17405",
"registration_state": "R",
"registration_number": "EU/1/21/1532/004"
}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.