| Code | 3943E | ||||||||||
| MA number | EU/1/19/1371/004 | ||||||||||
| Product Form: | sol inj 1x3,5 ml/245 mg (zás.jednor.napl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Alexion Europe SAS, France | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| 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: | 02.07.2019 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Ultomiris_Karta pacienta.pdf
|
| Dokument: |
Ultomiris_Prirucka pre lekarov.pdf
|
| Dokument: |
Ultomiris_Prirucka pre pacienta, rodicov a zakonnych zastupcov pacienta.pdf
|
| Safety feature | Yes |
| Data update: | 09.05.2024 |
