| 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 | ||||||||||
| MAH, country: | Ipsen Pharma, France | ||||||||||
| 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 |
