EMEA-000745-PIP01-09-M03
Key facts
| Active substance |
guanfacine hydrochloride
|
| Therapeutic area |
Psychiatry
|
| Decision number |
P/0265/2013
|
| PIP number |
EMEA-000745-PIP01-09-M03
|
| Pharmaceutical form(s) |
Prolonged-release tablet
|
| Condition(s) / indication(s) |
Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Takeda Pharmaceuticals International AG Ireland Branch
E-mail: medinfoemea@takeda.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000745-PIP01-09-M03
|
| Compliance opinion date |
06/12/2013
|
| Compliance outcome |
positive
|