Code | 7506E | ||||||||||
MA number | EU/1/23/1780/002 | ||||||||||
Product Form: | sol inj 1x3 ml/420 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | UCB Pharma S.A. , Belgium | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Container: | glass vial | ||||||||||
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: | 05.01.2024 |
Validity: | 05.01.2029 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 12.09.2024 |