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Product class:
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Authorized package
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Medicinal product class:
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Veterinary medicine
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Package code:
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1786776
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Name of medicinal product:
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Ototop
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Active substances:
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ATC code:
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QS02CA81
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Dosage form:
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ear drops, suspension
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Route of administration:
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cutaneous use; auricular use
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Strengh:
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5mg+23mg+5500RÜ 1ml
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Amount in package:
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100ml 1TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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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.
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Safety features:
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No
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Summary of product characteristics (SPC):
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 (last updated March 21, 2022)
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Package information leaflet (PIL):
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EST (last updated May 5, 2020)
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Labelling:
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(last updated March 21, 2022)
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Withdrawal time:
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Ei rakendata.
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Species:
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koer, kass, merisiga
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Livisto Int'l S.L.
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Marketing authorization number:
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2236
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Marketing authorization issued on:
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May 5, 2020
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Marketing authorization expires on:
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May 5, 2025
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Marketing authorization procedure type:
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Decentralised
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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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