EMEA-000309-PIP06-21
Key facts
Invented name |
RoActemra
|
Active substance |
tocilizumab
|
Therapeutic area |
Immunology-Rheumatology-Transplantation
|
Decision number |
P/0466/2021
|
PIP number |
EMEA-000309-PIP06-21
|
Pharmaceutical form(s) |
Solution for injection
|
Condition(s) / indication(s) |
Treatment of systemic sclerosis
|
Route(s) of administration |
Subcutaneous use
|
Contact for public enquiries |
Roche Registration GmbH
E-mail: info.paediatrics@roche.com |
Decision type |
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
|