EMEA-000597-PIP02-10-M07
Key facts
Invented name |
Betmiga
|
Active substance |
Mirabegron
|
Therapeutic area |
Uro-nephrology
|
Decision number |
P/0350/2017
|
PIP number |
EMEA-000597-PIP02-10-M07
|
Pharmaceutical form(s) |
|
Condition(s) / indication(s) |
Treatment of idiopathic overactive bladder
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Astellas Pharma Europe B.V.
E-mail: contact@nl.astellas.com
Tel. +31 715455878 |
Decision type |
RPM: decision refers to a refusal on the application for modification of an agreed PIP
|