Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 1707162
Name of medicinal product: Otoxolan
Active substances:
Estonian, English, Latin
ATC code: QS02CA85
Dosage form: ear drops, suspension
Route of administration: auricular use
Strengh: 0,9mg+3mg+10mg 1ml
Amount in package: 30ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Treatment of otitis externa of both bacterial and fungal origin respectively due to bacteria sensitive to marbofloxacin, and fungi especially Malassezia pachydermatis sensitive to clotrimazole.
Safety features: No
Summary of product characteristics (SPC):  (last updated June 28, 2024)
Package information leaflet (PIL): EST  (last updated June 28, 2024)
Labelling:  (last updated June 28, 2024)
Withdrawal time: Ei rakendata.
Species: koer
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: KRKA, d.d., Novo mesto 
Marketing authorization number: 1997 
Marketing authorization issued on: December 7, 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Entry/Changing date: June 28, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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