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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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1707140
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Name of medicinal product:
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Otoxolan
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Active substances:
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ATC code:
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QS02CA85
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Dosage form:
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ear drops, suspension
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Route of administration:
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auricular use
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Strengh:
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0,9mg+3mg+10mg 1ml
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Amount in package:
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10ml 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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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.
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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 January 27, 2022)
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Package information leaflet (PIL):
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EST (last updated January 27, 2022)
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Labelling:
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(last updated January 27, 2022)
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Withdrawal time:
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Ei rakendata.
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Species:
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koer
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Last imported to Estonia:
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August 28, 2023
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Marketing authorization holder:
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KRKA, d.d., Novo mesto
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Marketing authorization number:
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1997
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Marketing authorization issued on:
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December 7, 2016
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Decentralised
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Entry/Changing date:
November 16, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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