Poland· PL-100450798
Kesimpta
A ofatumumab product containing ofatumumabum, registered in Poland by Novartis Ireland Ltd. The same ATC class is registered in 10 of our 19 countries.
Checked against URPL (Poland) 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: Poland, from URPL (Poland)
- 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
URPL (Poland)- Active substance
- Ofatumumabum
- Manufacturer
- Novartis Ireland Ltd
- Country
- Poland (PL)
- ATC code
- L04AG12
- ATC class
- Ofatumumab
- Defined daily dose
- 0.67 mg, P
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin07613421040123
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.
- CzechiaKESIMPTANovartis Europharm Limited, Dublin
- 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
- 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 URPL (Poland). 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/e75b651b-a241-4512-bd0e-8e52267bc03d GET /v1/drugs/e75b651b-a241-4512-bd0e-8e52267bc03d?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": "Roztwór do wstrzykiwań we wstrzykiwaczu",
"source": "urpl",
"strength": "20 mg",
"packaging": "07613421040123 ¦ Rpz ¦ EU/1/21/1532/003 ¦ 139995\n1 wstrzykiwacz 0,4 ml\nRpz ¦ EU/1/21/1532/004 ¦ 139996\n3 wstrzykiwacze 0,4 ml opakowanie zbiorcze (3x1)",
"substance": "Ofatumumabum 20 mg",
"common_name": "Ofatumumabum",
"pl_product_id": "100450798",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}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.