OMLYCLO
As listed in the register: OMLYCLO 300 mg, solution injectable en seringue préremplie
300 mg · solution injectable
- Prescription only
- Active substance
- Omalizumab
- Made by
- CELLTRION HEALTHCARE HUNGARY (HONGRIE)
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (XOLAIR). It describes the substance, not this exact product.
Asthma, Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells.
In allergic asthmatics, treatment with omalizumab inhibits IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5, and IL-13.
Intact IgG was also excreted in bile.
IgE-Mediated Food Allergy Population pharmacokinetic (PK) analyses of omalizumab suggested that the PK of omalizumab in patients with IgE-mediated food allergy were generally consistent with that in patients with asthma.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-13
Safety of the active substance
From the US prescribing label for the same active substance (XOLAIR). It describes the substance, not this exact product.
WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR.
- XOLAIR is contraindicated in patients with severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR [see Warnings and Precautions (5.1) ].
- Severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR ( 4, 5.1 )
The most common adverse reactions (≥3% of patients) were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
European UnionNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | CELLTRION HEALTHCARE HUNGARY (HONGRIE) |
|---|---|
| Active substance | Omalizumab |
| Strength | 300 mg |
| Form | solution injectable |
| Route | sous-cutanée |
| Dispensing (as stated by the register) | prescription réservée aux spécialistes et services PEDIATRIE · prescription réservée aux spécialistes et services MEDECINE INTERNE · prescription réservée aux spécialistes et services PNEUMOLOGIE · prescription réservée aux spécialistes et services DERMATOLOGIE · liste I · prescription réservée aux spécialistes et services OTO-RHINO-LARYNGOLOGIE · prescription réservée aux spécialistes et services ALLERGOLOGIE |
| Marketed | Yes, according to the register |
| Reinforced monitoring | Yes — under reinforced monitoring, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/24/1817 |
| Name in the register | OMLYCLO 300 mg, solution injectable en seringue préremplie |
| Packs | 1 seringue préremplie en verre de 2 mL |
| CIS | 65804497 |
| CIP13 | 3400930328729 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).
Other strengths and forms
6 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- solution injectable6 products
75 mg2
75 mg · 2 companies
150 mg2
150 mg · 2 companies
300 mg2
300 mg · 2 companies
- CELLTRION HEALTHCARE HUNGARY (HONGRIE) · this page
- CELLTRION HEALTHCARE HUNGARY (HONGRIE)
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.