EMEA-002264-PIP01-17
Key facts
| Active substance |
Voclosporin
|
| Therapeutic area |
Immunology-Rheumatology-Transplantation
|
| Decision number |
P/0152/2019
|
| PIP number |
EMEA-002264-PIP01-17
|
| Pharmaceutical form(s) |
Capsule, soft
|
| Condition(s) / indication(s) |
Treatment of Systemic Lupus Erythematosus (SLE)
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Otsuka Pharmaceutical Netherlands B.V.
E-mail: paediatric-info@otsuka-europe.com |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|