Spain· ES:1241817014
OMLYCLO 300 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA
A medicinal product containing omalizumab, registered in Spain by Celltrion Healthcare Hungary Kft..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- omalizumab
- Manufacturer
- Celltrion Healthcare Hungary Kft.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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.
- CzechiaOMLYCLOCelltrion Healthcare Hungary Kft., Budapest
- BelgiumOmlyclo 300 mgCelltrion Healthcare Hungary
- SwedenOmlyclo 300 mg Injektionsvätska, lösning i förfylld injektionspennaCelltrion Healthcare Hungary Kft
- IcelandOmlycloCelltrion Healthcare Hungary Kft.
- PolandOmlycloCelltrion Healthcare Hungary Kft.
- NorwayOmlycloCelltrion Healthcare Hungary Kft.
- FinlandOmlycloParanova Oy
- FranceOMLYCLO 150 mg, solution injectable en seringue préremplieCELLTRION HEALTHCARE HUNGARY (HONGRIE)
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 AEMPS CIMA (Spain). 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/aaa3855e-b4ea-4042-9cf7-40e367371fa2 GET /v1/drugs/aaa3855e-b4ea-4042-9cf7-40e367371fa2?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.
{
"cpresc": "Diagnóstico Hospitalario",
"estado": "{\"aut\":1774340771000}",
"nregistro": "1241817014",
"substance": "omalizumab"
}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.