Otoxolan ear drops, suspension for dogs
Otoxolan ear drops, suspension for dogs
Authorised
- Dexamethasone acetate
- Clotrimazole
- Marbofloxacin
Product identification
Medicine name:
Otoxolan ear drops, suspension for dogs
Отоксолан капки за уши, суспензия за кучета
Active substance:
- Dexamethasone acetate
- Clotrimazole
- Marbofloxacin
Target species:
-
Dog
Route of administration:
-
Auricular use
Product details
Active substance and strength:
-
Dexamethasone acetate1.00milligram(s)1.00millilitre(s)
-
Clotrimazole10.00milligram(s)1.00millilitre(s)
-
Marbofloxacin3.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Ear drops, suspension
Withdrawal period by route of administration:
-
Auricular use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QS02CA06
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Bulgaria
Package description:
- Box containing 1 x 10 ml LDPE bottle with an LDPE dropper and HDPE screw cap, anda thermoplastic elastomer dropper with cap.
- Box containing 1 x 20 ml LDPE bottle with an LDPE dropper and HDPE screw cap, and2 thermoplastic elastomer dropper with cap.
- Box containing 1 x 30 ml LDPE bottle with an LDPE dropper and HDPE screw cap, and3 thermoplastic elastomer dropper with cap.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
- Tad Pharma GmbH
- Krka d.d. Novo Mesto
Responsible authority:
- Bulgarian Agency For Food Safety
Authorisation number:
- 0022-2691
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0438/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Czechia
-
Denmark
-
Estonia
-
France
-
Germany
-
Greece
-
Hungary
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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Package Leaflet and Labelling
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Bulgarian (PDF)
Published on: 25/03/2022
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