Code | 1497D | ||||||||||
MA number | EU/1/19/1362/001 | ||||||||||
Product Form: | sol inj 1x0,5 ml/2,5 mg (striek.inj.napl.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | BioMarin International Limited, Ireland | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 24 | ||||||||||
Container: | pre-filled syringe | ||||||||||
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: | 03.05.2019 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 09.05.2024 |