EMEA-001181-PIP01-11-M06
Key facts
| Invented name |
Valdoxan and associated names
|
| Active substance |
Agomelatine
|
| Therapeutic area |
Psychiatry
|
| Decision number |
P/0115/2021
|
| PIP number |
EMEA-001181-PIP01-11-M06
|
| Pharmaceutical form(s) |
Film-coated tablet
|
| Condition(s) / indication(s) |
Treatment of major depressive episodes
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Les Laboratoires Servier
E-mail: pip.enquiries@servier.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001181-PIP01-11-M06
|
| Compliance opinion date |
14/10/2022
|
| Compliance outcome |
positive
|