| Code | 9488B | ||||||||||
| MA number | EU/1/16/1101/001 | ||||||||||
| Product Form: | con inf 1x5 ml/100 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Janssen - Cilag International N.V., Belgium | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 20.05.2016 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Darzalex_Karta pacienta.pdf
|
| Dokument: |
Darzalex_Prirucka pre laboratoria.pdf
|
| Dokument: |
Darzalex_Prirucka pre zdravotnickych pracovnikov.pdf
|
| Safety feature | Yes |
| Data update: | 10.10.2022 |
