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Registers Irish medicines Ondibta 100 units/ml solution for injection in pre-filled pen
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Ondibta 100 units/ml solution for injection in pre-filled pen

Authorisation EU/1/25/2000/001-003 · Sandoz GmbH

Source: Health Products Regulatory Authority (HPRA), open dataset, CC BY 4.0. Published 16 Sep 2026
Licence holder
Sandoz GmbH (all products →)
Active substance
Insulin glargine
Dosage form
Solution for injection in pre-filled pen
Route of administration
Subcutaneous use
ATC code
A10AE04
First authorised
09/01/2026
Prescription status
*** AWAITING VALUE ***
Legal basis
Similar biological application (Article 10(4) of Directive No 2001/83/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.