| Code | 5993C | ||||||||||
| MA number | EU/1/11/700/003 | ||||||||||
| Product Form: | sol ira 1x1 ml/200 mg (striek.inj.skl. v napl.pere) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | GlaxoSmithKline (Ireland) Limited, Ireland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| 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: | 13.07.2011 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC Benlysta 3 4 2012.pdf
|
| Safety feature | Yes |
| Data update: | 13.05.2021 |
