EMEA-002375-PIP02-18

Key facts

Active substance
  • Dexamethasone (sodium phosphate)
  • levofloxacin
Therapeutic area
Oto-rhino-laryngology
Decision number
P/0242/2019
PIP number
EMEA-002375-PIP02-18
Pharmaceutical form(s)
Ear drops
Condition(s) / indication(s)
Treatment of acute otitis externa
Route(s) of administration
Auricular use
Contact for public enquiries
NTC srl

Tel.  +39 024385041
E-mail: federico.bertocchi@ntcpharma.com

Decision type
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan

Decision

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