EMEA-000118-PIP03-15
Key facts
| Invented name |
Orencia
|
| Active substance |
Abatacept
|
| Therapeutic area |
Immunology-Rheumatology-Transplantation
|
| Decision number |
P/0005/2017
|
| PIP number |
EMEA-000118-PIP03-15
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of Systemic Lupus Erythematosus (SLE)
|
| Route(s) of administration |
|
| Contact for public enquiries |
Bristol-Myers Squibb Pharma EEIG
|
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
Decision
-
List item
P/0005/2017: European Medicines Agency decision of 16 January 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for abatacept (Orencia), (EMEA-0001... (PDF/129.53 KB)
Adopted
First published: 17/03/2017
Last updated: 17/03/2017
EMA/13161/2017 -
List item
Orencia - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision (PDF/89.31 KB)
First published: 27/02/2019