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Medicinal Products

Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 1639537
Name of medicinal product: Mitex
Active substances:
Prednisolone+Miconazole+Polymyxin B
Estonian, English, Latin
ATC code: QS02CA81
Dosage form: ear drops, suspension
Route of administration: auricular use; cutaneous use
Strengh: 4,48mg+19,98mg+5500RÜ 1ml
Amount in package: 20ml 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 in dogs and cats caused by infections with the following miconazole and polymyxin B sensitive bacteria and fungi: • Gram-positive bacteria – Staphylococcus spp. – Streptococcus spp. • Gram-negative bacteria – Pseudomonas spp. – Escherichia coli • Yeasts and fungi – Malassezia pachydermatis – Candida spp. – Microsporum spp. – Trichophyton spp. Treatment of Otodectes cynotis infestations where there is concurrent infection with miconazole and polymyxin B sensitive pathogens.
Safety features: No
Summary of product characteristics (SPC):  (last updated October 22, 2019)
Package information leaflet (PIL): EST  (last updated October 22, 2019)
Labelling:  (last updated October 22, 2019)
Withdrawal time: Ei rakendata.
Species: koer, kass
Last imported to Estonia: May 26, 2022
Marketing authorization holder: Richter Pharma AG 
Marketing authorization number: 1899 
Marketing authorization issued on: March 11, 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Entry/Changing date: December 20, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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