Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Veterinary medicine
Name of medicinal product: Ototop
Active substances:
Prednisolone+Miconazole+Polymyxin B
Estonian, English, Latin
ATC code: QS02CA81
Dosage form: ear drops, suspension
Strength: 5mg+23mg+5500RÜ 1ml
Legal status for supply*: Subject to medicinal prescription
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)
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
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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1786754  Ototop  ear drops, suspension  5mg +23mg +5500RÜ 1ml 15ml 1TK  Prescription           
1786765  Ototop  ear drops, suspension  5mg +23mg +5500RÜ 1ml 30ml 1TK  Prescription           
1786776  Ototop  ear drops, suspension  5mg +23mg +5500RÜ 1ml 100ml 1TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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