Czechia· CZ-0250537

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.

ATC L04AG12

Checked against SÚKL (Czech Republic) on

Informational only — not a medical device.

SOURCE REGISTER · CZSÚKL (Czech Republic)normalisedKESIMPTAATCL04AG12REGISTER NO.CZ-0250537PACKS LISTED1CHECKEDSeptember 28, 2026

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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 · 1

1 priced
  • cz_kod_sukl
    0250537
    1X0,4ML
    CZK 34739.72

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All ofatumumab products

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/c5b58c81-cedf-4cc7-8f41-e2ca9f97c559
GET /v1/drugs/c5b58c81-cedf-4cc7-8f41-e2ca9f97c559?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": "1X0,4ML",
  "substance": "OFATUMUMAB",
  "cz_kod_sukl": "0250537",
  "product_type": "BT",
  "substance_codes": "17405",
  "registration_state": "R",
  "registration_number": "EU/1/21/1532/003"
}

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.