| Code | 2655E | ||||||||||
| MA number | EU/1/22/1695/001 | ||||||||||
| Product Form: | plc ifc 1x10 mg (liek.inj.skl.) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Swedish Orphan Biovitrum AB (publ), Sweden | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 60 | ||||||||||
| 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: | 20.12.2022 |
| Validity: | 22.12.2025 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Zynlonta_Karta pacienta.pdf
|
| Safety feature | Yes |
| Data update: | 06.12.2024 |
