| Code | 1095E | ||||||||||
| MA number | EU/1/21/1602/001 | ||||||||||
| Product Form: | con inf 3x10 ml/100 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Amgen Europe B.V., Netherland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 60 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 25.04.2022 |
| Validity: | 25.04.2027 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
UPLIZNA_Karta pacienta.pdf
|
| Safety feature | Yes |
| Data update: | 10.06.2025 |
