Code | 3165C | ||||||||||
MA number | EU/1/15/1016/007 | ||||||||||
Product Form: | sol inj 3 (3x1)x3,5 ml/420 mg (náplň plast.+3 (3x1) minidávk.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Amgen Europe B.V., Netherland | ||||||||||
Therapeutic Class: | 31 - HYPOLIPIDAEMICA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 24 | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 17.02.2017 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 27.04.2020 |