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
|