EMEA-000228-PIP01-08-M04
Key facts
| Invented name |
Sycrest
|
| Active substance |
Asenapine maleate
|
| Therapeutic area |
Psychiatry
|
| Decision number |
P/0299/2014
|
| PIP number |
EMEA-000228-PIP01-08-M04
|
| Pharmaceutical form(s) |
Sublingual tablet
|
| Condition(s) / indication(s) |
Treatment of bipolar I disorder
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
N.V. Organon
E-mail: regaffairseurope@organon.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000228-PIP01-08-M04
|
| Compliance opinion date |
18/08/2017
|
| Compliance outcome |
positive
|