Code | 4486E |
MA number | EU/1/23/1759/002 |
Product Form: | sol inj 1x0,8 ml/48 mg (liek.inj.skl.) |
MA Status: | Ex - Conditional centralised marketing authorisation |
Type of procedure: | EU Orphan |
MAH, country: | AbbVie Deutschland GmbH & Co. KG, Germany |
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: | 05.08.2024 |