EMEA-000395-PIP01-08
Key facts
| Invented name |
Buccolam
|
| Active substance |
Midazolam Hydrochloride
|
| Therapeutic area |
Neurology
|
| Decision number |
P/155/2009
|
| PIP number |
EMEA-000395-PIP01-08
|
| Pharmaceutical form(s) |
Oromucosal solution
|
| Condition(s) / indication(s) |
Epileptic seizures
|
| Route(s) of administration |
Oromucosal use
|
| Contact for public enquiries |
Auralis Limited
|
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
| Compliance procedure number |
EMEA-C-000395-PIP01-08
|
| Compliance opinion date |
06/08/2010
|
| Compliance outcome |
positive
|