Ototop Ear Drops and Cutaneous Suspension for Dogs, Cats and Guinea Pigs
Ototop Ear Drops and Cutaneous Suspension for Dogs, Cats and Guinea Pigs
Authorised
- Miconazole nitrate
- Prednisolone acetate
- POLYMYXIN B SULFATE
Product identification
Medicine name:
Ototop Ear Drops and Cutaneous Suspension for Dogs, Cats and Guinea Pigs
Ototop, ausų lašai ir odos suspensija šunims, katėms ir jūrų kiaulytėms
Active substance:
- Miconazole nitrate
- Prednisolone acetate
- POLYMYXIN B SULFATE
Target species:
-
Dog
-
Cat
-
Guinea pig
Route of administration:
-
Cutaneous use
-
Auricular use
Product details
Active substance and strength:
-
Miconazole nitrate23.00milligram(s)1.00millilitre(s)
-
Prednisolone acetate5.00milligram(s)1.00millilitre(s)
-
POLYMYXIN B SULFATE0.53milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Cutaneous/ear drops suspension
Withdrawal period by route of administration:
-
Cutaneous use
- Dog
- Cat
- Guinea pig
-
Auricular use
- Dog
- Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QS02CA01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Lithuania
Package description:
- (ID3) 100 millilitre(s): Box (Cardboard) with 1 Bottle (Low Density PolyEthylene) with 100 millilitre(s), closed with Screw cap (PolyPropylene)
- (ID2) 30 millilitre(s): Box (Cardboard) with 1 Bottle (Low Density PolyEthylene) with 30 millilitre(s), closed with Screw cap (PolyPropylene)
- (ID1) 15 millilitre(s): Box (Cardboard) with 1 Bottle (Low Density PolyEthylene) with 15 millilitre(s), closed with Screw cap (PolyPropylene)
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Livisto Int'l S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
- Industrial Veterinaria S.A.
- Animedica Herstellungs GmbH
- Animedica GmbH
Responsible authority:
- State Food And Veterinary Service
Authorisation number:
- LT/2/20/2602/001-003
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0321/001
Concerned member states:
-
Austria
-
Belgium
-
Cyprus
-
Czechia
-
Estonia
-
Greece
-
Hungary
-
Italy
-
Latvia
-
Lithuania
-
Malta
-
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
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