Ireland· IE-PA-EU/1/05/319/8-10
Xolair 150 mg solution for injection in pre-filled syringe
A omalizumab product containing omalizumab, registered in Ireland by Novartis Europharm Limited. The same ATC class is registered in 16 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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
Omalizumab · ATC R03DX05
16 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Italyprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
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
Omalizumab · price per daily dose (16 mg)
USD · FX 28 Sept 2026
- CH Switzerland$48.02
- CZ Czechia$0.26
The record
At a glance
HPRA (Ireland)- Active substance
- Omalizumab
- Manufacturer
- Novartis Europharm Limited
- 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_numberEU/1/05/319/8-10
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
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.
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.
- FranceOMLYCLO 150 mg, solution injectable en seringue préremplieCELLTRION HEALTHCARE HUNGARY (HONGRIE)
- NetherlandsOmlyclo 150 mg oplossing voor injectie in een voorgevulde penCelltrion Healthcare Hungary Kft.
- CzechiaOMLYCLOCelltrion Healthcare Hungary Kft., Budapest
- FinlandOmlycloCelltrion Healthcare Hungary Kft.
- SwedenOmlyclo 150 mg Injektionsvätska, lösning i förfylld injektionspennaCelltrion Healthcare Hungary Kft
- BelgiumOmlyclo 150 mgCelltrion Healthcare Hungary
- PolandOmlycloCelltrion Healthcare Hungary Kft.
- IcelandOmlycloCelltrion Healthcare Hungary Kft.
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/ecc92087-0c94-48de-bc13-76481c3b7f7a GET /v1/drugs/ecc92087-0c94-48de-bc13-76481c3b7f7a?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": [
"R03DX",
"R03DX05"
],
"strength": null,
"pa_number": "EU/1/05/319/8-10",
"substances": [
"Omalizumab"
],
"legal_basis": "New active substance (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 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.