| 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 |
