Code | 5999D | ||||||||||
MA number | EU/1/20/1485/001 | ||||||||||
Product Form: | con inf 1x6 ml/600 mg (liek.inj.skl.) | ||||||||||
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | SFL Pharmaceuticals Deutschland GmbH, Germany | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 84 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 18.11.2020 |
Validity: | 18.11.2025 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 22.05.2023 |