Iceland· IS-EU/1/21/1532/001-002
Kesimpta
A ofatumumab product containing ofatumumabum inn, registered in Iceland by Novartis Europharm Limited*. The same ATC class is registered in 10 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Ofatumumabum INN
- Manufacturer
- Novartis Europharm Limited*
- Country
- Iceland (IS)
- ATC code
- L04AG12
- ATC class
- Ofatumumab
- Defined daily dose
- 0.67 mg, P
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 1
1 priced- ean0311720,4 ml x1 áfpenISK 234338
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
- PolandKesimptaNovartis Ireland Ltd
- SwedenKesimpta 20 mg Injektionsvätska, lösning i förfylld injektionspennaNovartis Europharm Limited
- SpainKESIMPTA 20 mg SOLUCION INYECTABLE EN PLUMA PRECARGADANovartis Europharm Limited
- BelgiumKesimpta 20 mgNovartis Europharm
- 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 2 EEA countries. Names it is sold under:
- 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 Icelandic Medicines Agency (Iceland). 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/9c227434-8b0b-4dde-be04-654797c213a9 GET /v1/drugs/9c227434-8b0b-4dde-be04-654797c213a9?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": "Stungulyf, lausn í áfylltri sprautu",
"source": "lyfjastofnun",
"atc_raw": "L04AG12",
"marketed": false,
"strength": "20 mg",
"ma_number": "EU/1/21/1532/001-002",
"substance": "Ofatumumabum INN",
"other_info": "Ávísun lyfsins er bundin við sérfræðinga í taugasjúkdómum.",
"legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
"ma_issued_serial": "44281"
}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.