EMEA-002375-PIP02-18
Key facts
Active substance |
|
Therapeutic area |
Oto-rhino-laryngology
|
Decision number |
P/0242/2019
|
PIP number |
EMEA-002375-PIP02-18
|
Pharmaceutical form(s) |
Ear drops, solution
|
Condition(s) / indication(s) |
Treatment of acute otitis externa
|
Route(s) of administration |
Auricular use
|
Contact for public enquiries |
NTC srl
Tel. +39 024385041 |
Decision type |
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
|