Skúšobnú verziu novej webovej stránky nájdete na beta.sukl.sk. Všetky aktuality, informácie a kompletný obsah sú zatiaľ prioritne dostupné na pôvodnej verzii webu.
en

PRODUCT DETAIL

Ondibta 100 jednotiek/ml injekčný roztok v naplnenom pere

Code 2540F
MA number EU/1/25/2000/001
Product Form: sol ira 1x3 ml/300 jednotiek (pero napl. - VitaClick)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Gan & Lee Pharmaceuticals Europe GmbH, Germany
Therapeutic Class: 18 - ANTIDIABETICA (VRÁTANE INZULÍNU)
ATC:
A ALIMENTARY TRACT AND METABOLISM
A10 DRUGS USED IN DIABETES
A10A INSULINS AND ANALOGUES
A10AE Insulins and analogues, for injection, long-acting
A10AE04 Insulin glargine
Shelf life: 36
Container: pre-filled pen
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(4) similar biological application
MA issued: 09.01.2026
Validity: 09.01.2031
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 02.02.2026
eu-flag.png sk-flag.png