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Belgium· BE-AMP-SAM665326-00

Omlyclo 300 mg

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

ATC R03DX05

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedOmlyclo 300 mgATCR03DX05REGISTER NO.BE-AMP-SAM665326-00PACKS LISTED3CHECKEDSeptember 26, 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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Omalizumab
Manufacturer
Celltrion Healthcare Hungary
Country
Belgium (BE)
ATC code
R03DX05
ATC class
Omalizumab
Defined daily dose
16 mg, P
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 3

2 priced
  • be_apb
    4986188
    EUR 912.63
  • be_apb
    4986261
    EUR 311.52
  • be_apb
    7750532

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 FAMHP / AFMPS (Belgium). 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/c6c9ea7f-eae8-4de4-bee3-ab6a431459ac
GET /v1/drugs/c6c9ea7f-eae8-4de4-bee3-ab6a431459ac?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Omlyclo 300 mg",
  "name_fr": "Omlyclo 300 mg",
  "name_nl": "Omlyclo 300 mg",
  "amp_code": "SAM665326-00",
  "strengths": [
    "300.0000",
    "300.0000",
    "0.4000"
  ],
  "pack_count": 4,
  "substances": [
    "Omalizumab",
    "Polysorbate 20"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Omalizumab",
  "authorisation_numbers": [
    "EU/1/24/1817/014",
    "EU/1/24/1817/015",
    "EU/1/24/1817/017",
    "EU/1/24/1817/016"
  ]
}
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