| Code | 4486E | ||||||||||
| MA number | EU/1/23/1759/002 | ||||||||||
| Product Form: | sol inj 1x0,8 ml/48 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | AbbVie Deutschland GmbH & Co. KG, Germany | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 22.09.2023 |
| Validity: | 25.09.2025 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Epkoritamab_Karta pacienta_20Dec2023_final.pdf
|
| Safety feature | Yes |
| Data update: | 14.03.2025 |
