Ireland· IE-PA-EU/1/21/1532/001-002
Kesimpta 20 mg solution for injection in pre-filled syringe
A ofatumumab product containing ofatumumab, registered in Ireland by Novartis Europharm Limited.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Ofatumumab
- Manufacturer
- Novartis Europharm Limited
- Country
- Ireland (IE)
- ATC code
- L01XC10
- ATC class
- Ofatumumab
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/21/1532/001-002
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.
- NetherlandsKesimpta 20 mg, oplossing voor injectie in voorgevulde penNovartis Europharm Limited
- FranceKESIMPTA 20 mg, solution injectable en stylo prérempliNOVARTIS EUROPHARM (IRLANDE)
- CzechiaKESIMPTANovartis Europharm Limited, Dublin
- BelgiumArzerra 100 mgNovartis Europharm
- FinlandArzerraNovartis Europharm Limited
- United KingdomArzerra 1000mg/50ml concentrate for solution for infusion vialsNovartis Pharmaceuticals UK Ltd
- IcelandKesimptaNovartis Europharm Limited*
- SpainKESIMPTA 20 mg SOLUCION INYECTABLE EN PLUMA PRECARGADANovartis 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 HPRA (Ireland). 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/cee7fee9-42a9-45aa-9b48-29935818ad76 GET /v1/drugs/cee7fee9-42a9-45aa-9b48-29935818ad76?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": "Solution for injection in pre-filled syringe",
"routes": [
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"L01XC10"
],
"strength": null,
"pa_number": "EU/1/21/1532/001-002",
"substances": [
"Ofatumumab"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "26/03/2021",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": 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.