EMEA-000308-PIP02-11-M01
Key facts
| Invented name |
MabThera
|
| Active substance |
rituximab
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0060/2016
|
| PIP number |
EMEA-000308-PIP02-11-M01
|
| Pharmaceutical form(s) |
Concentrate for solution for infusion
|
| Condition(s) / indication(s) |
Treatment of microscopic polyangiitis
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Roche Registration Limited
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000308-PIP02-11-M01
|
| Compliance opinion date |
01/02/2019
|
| Compliance outcome |
positive
|