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Ireland· IE-PA-EU/1/24/1817/001

Omlyclo 75 mg solution for injection in pre-filled syringe

A omalizumab product containing omalizumab, registered in Ireland by Celltrion Healthcare Hungary Kft.. The same ATC class is registered in 16 of our 19 countries.

ATC R03DX05

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedOmlyclo 75 mg solution for injection …ATCR03DX05REGISTER NO.IE-PA-EU/1/24/1817/001PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about omalizumabAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Omalizumab is registered in 16 of 19 countries.

Countries holding a registration under ATC R03DX05 (omalizumab), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 10 of them publish a price we can compare per daily dose
Search omalizumab products by name

Omalizumab · ATC R03DX05

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
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.

Price per daily dose

What a daily dose of omalizumab costs, country by country.

Normalised to the WHO defined daily dose (16 mg), the median price runs from $0.26 in Czechia to $48.02 in Switzerland — a ×186 gap.

  • 2 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Omalizumab · price per daily dose (16 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$48.02
  • CZ Czechia$0.26
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

HPRA (Ireland)
Active substance
Omalizumab
Manufacturer
Celltrion Healthcare Hungary Kft.
Country
Ireland (IE)
ATC code
R03DX05
ATC class
Omalizumab
Defined daily dose
16 mg, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/24/1817/001

Regulatory notes

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

Interactions

8 interactions on record for omalizumab.

Graded by severity as the source publishes them — 1 moderate. 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
Check omalizumab against other medicinesHow interaction checks work

Omalizumab · interactions on record

8 records

  • 1 moderate
  • 7 minor

Most severe, free to view

  • Omacetaxine mepesuccinateL01XX40moderate
  • 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

Omalizumab in 16 other countries

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

All omalizumab products

Authorised across Europe · EMA

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

  • Iceland · Omlyclo, Xolair
  • Liechtenstein · Omlyclo, Xolair
  • Norway · Omlyclo, Xolair

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/d922d292-ed0a-4fd2-8ab4-3254daed1167
GET /v1/drugs/d922d292-ed0a-4fd2-8ab4-3254daed1167?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": [
    "R03DX05"
  ],
  "strength": null,
  "pa_number": "EU/1/24/1817/001",
  "substances": [
    "Omalizumab"
  ],
  "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "16/05/2024",
  "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
}
API referenceMCP serverPlans

See everything about omalizumab.

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.

Try it freeOpen in the console