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Medicinal Products

Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 1786754
Name of medicinal product: Ototop
Active substances:
Prednisolone+Miconazole+Polymyxin B
Estonian, English, Latin
ATC code: QS02CA81
Dosage form: ear drops, suspension
Route of administration: cutaneous use; auricular use
Strengh: 5mg+23mg+5500RÜ 1ml
Amount in package: 15ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: For the treatment of infection of external auditory canal (otitis externa) in dogs and cats as well as primary and secondary infections of the skin and skin adnexa (hair, nails, sweat glands) in dogs, cats and guinea pigs, caused by the following miconazole and polymyxin B susceptible pathogens: • Fungi (including yeasts) - Malassezia pachydermatis - Candida spp. - Microsporum spp. - Trichophyton spp. • Gram-positive bacteria - Staphylococcus spp. - Streptococcus spp. • Gram-negative bacteria - Pseudomonas spp. - Escherichia coli • For the adjunct treatment of an infestation with Otodectes cynotis (ear mites) associated with Otitis externa.
Safety features: No
Summary of product characteristics (SPC):  (last updated March 21, 2022)
Package information leaflet (PIL): EST  (last updated May 5, 2020)
Labelling:  (last updated March 21, 2022)
Withdrawal time: Ei rakendata.
Species: koer, kass, merisiga
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Livisto Int'l S.L. 
Marketing authorization number: 2236 
Marketing authorization issued on: May 5, 2020 
Marketing authorization expires on: May 5, 2025 
Marketing authorization procedure type: Decentralised 
Entry/Changing date: March 18, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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