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Ireland· IE-PA-EU/1/13/869/001

LEMTRADA 12 mg concentrate for solution for infusion

A alemtuzumab product containing alemtuzumab, registered in Ireland by Sanofi Belgium.

ATC L04AA34

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedLEMTRADA 12 mg concentrate for soluti…ATCL04AA34REGISTER NO.IE-PA-EU/1/13/869/001PACKS LISTED1CHECKEDSeptember 28, 2026

The record

At a glance

HPRA (Ireland)
Active substance
Alemtuzumab
Manufacturer
Sanofi Belgium
Country
Ireland (IE)
ATC code
L04AA34
ATC class
Alemtuzumab
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/13/869/001

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

338 interactions on record for alemtuzumab.

Graded by severity as the source publishes them — 24 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

Alemtuzumab · interactions on record

338 records

  • 24 severe
  • 314 moderate

Most severe, free to view

  • CladribineL01BB04severe
  • PrednisoloneA07EA01moderate
  • HydrocortisoneA07EA02moderate
  • PrednisoneA07EA03moderate
  • 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

Alemtuzumab in 13 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All alemtuzumab products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Lemtrada
  • Liechtenstein · Lemtrada
  • Norway · Lemtrada

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/30c7b978-c3b9-467e-b782-980dffbee176
GET /v1/drugs/30c7b978-c3b9-467e-b782-980dffbee176?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": "Concentrate for solution for infusion",
  "routes": [
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "L04AA",
    "L04AA34"
  ],
  "strength": null,
  "pa_number": "EU/1/13/869/001",
  "substances": [
    "Alemtuzumab"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": null,
  "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 alemtuzumab.

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.