| Code | 35677 | ||||||||||
| MA number | EU/1/06/346/001 | ||||||||||
| Product Form: | con inf 1x15 ml/300 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Biogen Netherlands B.V., Netherland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| 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: | 27.06.2006 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC Tysabri 18 3 2016.pdf
|
| Dokument: |
DHPC Tysabri_DHPC 24 3 2010.pdf
|
| Dokument: |
Tysabri_Doplnkové informácie pre zdravotníckych pracovníkov.pdf
|
| Dokument: |
Tysabri_Formulár o pokračovaní v liečbe.pdf
|
| Dokument: |
Tysabri_Formulár o ukončení liečby.pdf
|
| Dokument: |
Tysabri_Formulár o začatí liečby.pdf
|
| Dokument: |
Tysabri_Informácie pre lekárov a usmernenia k liečbe.pdf
|
| Dokument: |
Tysabri_Kontrolný zoznam pred podaním lieku.pdf
|
| Dokument: |
Tysabri_Karta pre pacienta.pdf
|
| Safety feature | Yes |
| Data update: | 22.10.2024 |
