| Code | 3576E | ||||||||||
| MA number | EU/1/23/1727/001 | ||||||||||
| Product Form: | con inf 1x30 ml/300 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Amgen Technology (Ireland) UC, Ireland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(4) similar biological application |
| MA issued: | 19.04.2023 |
| Validity: | 19.04.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
BEKEMV Karta pacienta.pdf
|
| Dokument: |
BEKEMV_Príručka pre lekára.pdf
|
| Dokument: |
BEKEMV_Príručka pre pacienta_rodiča.pdf
|
| Safety feature | Yes |
| Data update: | 06.02.2024 |
