Omlyclo 300 mg solution for injection in pre-filled syringe

Licence holder

Celltrion Healthcare Hungary Kft. (all products →)

Active substance

Omalizumab

Dosage form

Solution for injection in pre-filled syringe

Route of administration

Subcutaneous use

ATC code

R03DX05

First authorised

10/11/2025

Prescription status

Product subject to prescription which may not be renewed (A)

Supply

Supply through pharmacies only

Legal basis

Similar biological application (Article 13(4) of Directive No 2001/82/EC)

This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.