Code | 4514E | ||||||||||
MA number | 59/0231/23-S | ||||||||||
Product Form: | sol inj 1x1,2 ml/24 mg (liek.inj.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | ONKOGEN Kft., Hungary | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 23.10.2023 |
Validity: | 23.10.2028 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
SPC: | SPC_Plerixafor Onkogen 20 mg_ml injekčný roztok_10 2023.pdf |
PIL: | PIL_Plerixafor Onkogen 20 mg_ml injekčný roztok_01.2024.pdf |
Safety feature | Yes |
Data update: | 14.11.2023 |