Code | 1840E | ||||||||||
MA number | 44/0224/22-S | ||||||||||
Product Form: | plv inu 1x100 mg (liek.inj.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Zentiva k.s., Czechia | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
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: | 23.08.2022 |
Validity: | 23.08.2027 |
PIL: | PIL_Azacitidine Zentiva_12.2023.pdf |
SPC: | SPC_Azacitidine Zentiva_07.2024.pdf |
Safety feature | Yes |
Data update: | 19.07.2024 |