Osurnia 10 mg/10 mg/1 mg - Ear gel
Osurnia 10 mg/10 mg/1 mg - Ear gel
Authorised
- Terbinafine
- Florfenicol
- Betamethasone acetate
Product identification
Medicine name:
Osurnia 10 mg/10 mg/1 mg - Ear gel
Active substance:
- Terbinafine
- Florfenicol
- Betamethasone acetate
Target species:
-
Dog
Route of administration:
-
Auricular use
Product details
Active substance and strength:
-
Terbinafine10.00/milligram(s)1.00Tube
-
Florfenicol10.00/milligram(s)1.00Tube
-
Betamethasone acetate1.00/milligram(s)1.00Tube
Pharmaceutical form:
-
Ear gel
Withdrawal period by route of administration:
-
Auricular use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QS02CA90
Legal status of supply:
-
Medicinal product subject to medical prescription
Authorisation status:
-
Valid
Authorised in:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Liechtenstein
-
Lithuania
-
Luxembourg
-
Malta
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
Package description:
- Packaging:Tube (Alu/PE) with PP elastomer tip, Package_size:40 tubes, Content:2,05 g
- Packaging:Tube (Alu/PE) with PP elastomer tip, Package_size:20 tubes, Content:2,05 g
- Packaging:Tube (Alu/PE) with PP elastomer tip, Package_size:12 tubes, Content:2,05 g
- Packaging:Tube (Alu/PE) with PP elastomer tip, Package_size:2 tubes, Content:2,05 g
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Dechra Regulatory B.V
Marketing authorisation date:
Manufacturing sites for batch release:
- Argenta Dundee Limited
- Genera d.d.
Responsible authority:
- European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 18/11/2022
Bulgarian (PDF)
Published on: 18/11/2022
Croatian (PDF)
Published on: 18/11/2022
Czech (PDF)
Published on: 18/11/2022
Danish (PDF)
Published on: 18/11/2022
Dutch (PDF)
Published on: 18/11/2022
Estonian (PDF)
Published on: 18/11/2022
Finnish (PDF)
Published on: 18/11/2022
French (PDF)
Published on: 18/11/2022
German (PDF)
Published on: 18/11/2022
Greek (PDF)
Published on: 18/11/2022
Hungarian (PDF)
Published on: 18/11/2022
Icelandic (PDF)
Published on: 18/11/2022
Italian (PDF)
Published on: 18/11/2022
Latvian (PDF)
Published on: 18/11/2022
Lithuanian (PDF)
Published on: 18/11/2022
Maltese (PDF)
Published on: 18/11/2022
Norwegian (PDF)
Published on: 18/11/2022
Polish (PDF)
Published on: 18/11/2022
Portuguese (PDF)
Published on: 18/11/2022
Romanian (PDF)
Published on: 18/11/2022
Slovak (PDF)
Published on: 18/11/2022
Slovenian (PDF)
Published on: 18/11/2022
Spanish (PDF)
Published on: 18/11/2022
Swedish (PDF)
Published on: 18/11/2022
ema-puar-osurnia-epar-public-assessment-report-en.pdf
English (PDF)
Download Published on: 15/03/2023
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