Code | 44951 | ||||||||||
MA number | EU/1/07/402/001 | ||||||||||
Product Form: | sol inj 1x4 ml/40 mg (liek.skl.) | ||||||||||
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
Type of procedure: | EU | ||||||||||
Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass container | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 03.08.2007 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | DHPC Increlex 7 1 2014.pdf |
Dokument: | Increlex_Informácia pre lekára.pdf |
Dokument: | Increlex_Informácie o hypoglykémii.pdf |
Dokument: | Increlex_Dôležite informácie a minimalizacii rizika pre pacientov.pdf |
Safety feature | Yes |
Data update: | 06.05.2021 |