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PRODUCT DETAIL

Semglee 100 jednotiek/ml injekčný roztok v naplnenom pere

Code 7538C
MA number EU/1/18/1270/002
Product Form: sol inj 3x3 ml/300 jednotiek (náplň skl. v pere)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Biosimilar Collaborations Ireland Limited, Ireland
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: glass cartridge in 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: 23.03.2018
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 03.03.2023
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