EMEA-000573-PIP02-13-M03
Key facts
Invented name |
Vesicare and associated names
|
Active substance |
Solifenacin (succinate)
|
Therapeutic area |
Uro-nephrology
|
Decision number |
P/0115/2015
|
PIP number |
EMEA-000573-PIP02-13-M03
|
Pharmaceutical form(s) |
|
Condition(s) / indication(s) |
Treatment of neurogenic detrusor overactivity
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Astellas Pharma Europe B.V.
|
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-000573-PIP02-13-M03
|
Compliance opinion date |
16/12/2016
|
Compliance outcome |
positive
|