EMEA-001207-PIP02-19
Key facts
| Invented name |
Gazyvaro
|
| Active substance |
Obinutuzumab
|
| Therapeutic area |
Immunology-Rheumatology-Transplantation
|
| Decision number |
P/0050/2021
|
| PIP number |
EMEA-001207-PIP02-19
|
| Pharmaceutical form(s) |
Concentrate for solution for infusion
|
| Condition(s) / indication(s) |
Treatment of Systemic Lupus Erythematosus (SLE)
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Roche Registration GmbH
Tel. +41 616879411 |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|