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Medicinal Products

Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 3021286
Name of medicinal product: Orilane
Active substances:
Prednisolone+Miconazole+Polymyxin B
Estonian, English, Latin
ATC code: QS02CA81
Dosage form: ear drops, suspension
Route of administration: cutaneous 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 otitis externa and small, localised, superficial skin infections caused by mixed infections with the following miconazole and polymixin B susceptible bacteria and fungi: ? Gram-positive bacteria: Staphylococcus spp. and Streptococcus spp. ? Gram-negative bacteria: Pseudomonas spp. and Escherichia coli ? Fungi: Malassezia pachydermatis, Candida spp., Microsporum spp. and Trichophyton spp. Treatment of Otodectes cynotis (ear mites) infestations where there is concurrent infection with bacteria and fungi susceptible to polymyxin B and miconazole.
Safety features: No
Summary of product characteristics (SPC):  (last updated September 4, 2023)
Package information leaflet (PIL): EST  (last updated September 4, 2023)
Labelling:  (last updated September 4, 2023)
Withdrawal time: Ei rakendata.
Species: kass, koer
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Chanelle Pharmaceuticals Manufacturing Limited 
Marketing authorization number: 1125223 
Marketing authorization issued on: September 4, 2023 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Entry/Changing date: May 14, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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