| Code | 9504B | ||||||||||
| MA number | EU/1/98/067/004 | ||||||||||
| Product Form: | sol inj 1x13,4 ml/1600 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Roche Registration GmbH, Germany | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application |
| MA issued: | 02.06.1998 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
MabThera DHCP 04 11 2009 SK.pdf
|
| Dokument: |
DHPC MabThera 8 11 2013.pdf
|
| Dokument: |
DHPC MabThera TEN and SJS 12 4 2013.pdf
|
| Dokument: |
DHPC MabThera Informacia 15 8 2011.pdf
|
| Dokument: |
rituximab_Karta_pacienta.pdf
|
| Safety feature | Yes |
| Data update: | 29.07.2024 |
