Ireland· IE-PA-EU/1/11/700/001-002
Benlysta 120 mg powder for concentrate for solution for infusion
A belimumab product containing belimumab, registered in Ireland by GlaxoSmithKline (Ireland) Limited.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Belimumab
- Manufacturer
- GlaxoSmithKline (Ireland) Limited
- Country
- Ireland (IE)
- ATC code
- L04AA26
- ATC class
- Belimumab
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/11/700/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
61 interactions on record for belimumab.
Graded by severity as the source publishes them — 28 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
Belimumab · interactions on record
61 records
- 28 severe
- 26 moderate
- 7 minor
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
Belimumab in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandBenlystaOrifarm Oy
- CzechiaBENLYSTAGlaxoSmithKline (Ireland) Limited, Dublin
- SpainBENLYSTA 120 mg POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONGlaxosmithkline (Ireland) Limited
- United KingdomBenlysta 120mg powder for concentrate for solution for infusion vialsGlaxoSmithKline UK Ltd
- IcelandBenlystaGlaxoSmithKline (Ireland) Limited
- NorwayBenlystaGlaxoSmithKline (Ireland) Limited
- PolandBenlystaGlaxoSmithKline (Ireland) Limited
- BelgiumBenlysta 120 mgGlaxoSmithKline
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Benlysta
- Liechtenstein · Benlysta
- Norway · Benlysta
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/e07c8c6e-9508-4f26-8905-d7d7fc1b2ff3 GET /v1/drugs/e07c8c6e-9508-4f26-8905-d7d7fc1b2ff3?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": "Powder for concentrate for solution for infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"L04AA",
"L04AA26"
],
"strength": null,
"pa_number": "EU/1/11/700/001-002",
"substances": [
"Belimumab"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "13/07/2011",
"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 belimumab.
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.