Product class:
|
Authorized package
|
Medicinal product class:
|
Veterinary medicine
|
Package code:
|
1661251
|
Name of medicinal product:
|
Osurnia
|
Active substances:
|
|
ATC code:
|
QS02CA92
|
Dosage form:
|
ear gel
|
Route of administration:
|
auricular use
|
Strengh:
|
0,9mg+10mg+10mg 1.2g
|
Amount in package:
|
1.2g 12TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Treatment of acute otitis externa and acute exacerbation of recurrent otitis externa associated with Staphylococcus pseudintermedius and Malassezia pachydermatis.
|
Safety features:
|
No
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Withdrawal time:
|
Ei rakendata.
|
Species:
|
koer
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Dechra Regulatory B.V.
|
Marketing authorization number:
|
EU/2/14/170
|
Marketing authorization issued on:
|
July 31, 2014
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Entry/Changing date:
September 25, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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