EMEA-000553-PIP01-09-M05
Key facts
| Invented name |
Elvanse and associated names
|
| Active substance |
Lisdexamfetamine dimesilate
|
| Therapeutic area |
Psychiatry
|
| Decision number |
P/0097/2022
|
| PIP number |
EMEA-000553-PIP01-09-M05
|
| Pharmaceutical form(s) |
Capsule, hard
|
| 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
+44 (0)3333 000181 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000553-PIP01-09-M05
|
| Compliance opinion date |
25/05/2022
|
| Compliance outcome |
positive
|