Code | 43567 | ||||||||||
MA number | EU/1/07/393/001 | ||||||||||
Product Form: | con inf 1x30 ml/300 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
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: | 20.06.2007 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | SOLIRIS_Karta pacienta.pdf |
Dokument: | SOLIRIS_Prirucka pre lekarov.pdf |
Dokument: | SOLIRIS_Prirucka pre pacienta.pdf |
Safety feature | Yes |
Data update: | 21.11.2023 |