Code | 1095E | ||||||||||
MA number | EU/1/21/1602/001 | ||||||||||
Product Form: | con inf 3x10 ml/100 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Horizon Therapeutics Ireland DAC, Ireland | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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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: | 25.04.2022 |
Validity: | 25.04.2027 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | Uplizna_Karta pacienta.pdf |
Safety feature | Yes |
Data update: | 16.07.2024 |