| Code | 4525E | ||||||||||
| MA number | EU/1/23/1754/001 | ||||||||||
| Product Form: | con inf 1x4 ml/80 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Fresenius Kabi Deutschland GmbH, Germany | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(4) similar biological application |
| MA issued: | 15.09.2023 |
| Validity: | 15.09.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
tocilizumab_prirucka pre pacienta.pdf
|
| Dokument: |
tocilizumab_prirucka k podavaniu lieku.pdf
|
| Dokument: |
tocilizumab_prirucka pre zdravotnickych pracovnikov.pdf
|
| Dokument: |
tocilizumab_karta pacienta.pdf
|
| Safety feature | Yes |
| Data update: | 06.10.2023 |
