SUROLAN, kapi za uho i suspenzija za kožu za pse i mačke
SUROLAN, kapi za uho i suspenzija za kožu za pse i mačke
Not authorised
- Miconazole nitrate
- Prednisolone acetate
- POLYMYXIN B SULFATE
Product identification
Medicine name:
SUROLAN, kapi za uho i suspenzija za kožu za pse i mačke
Active substance:
- Miconazole nitrate
- Prednisolone acetate
- POLYMYXIN B SULFATE
Target species:
-
Dog
-
Cat
Route of administration:
-
Cutaneous use
-
Auricular use
Product details
Active substance and strength:
-
Miconazole nitrate23.00/milligram(s)1.00millilitre(s)
-
Prednisolone acetate5.00/milligram(s)1.00millilitre(s)
-
POLYMYXIN B SULFATE0.53/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Cutaneous/ear drops suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QD01AC52
Legal status of supply:
-
Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
-
Surrendered
Authorised in:
-
Croatia
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- Lusomedicamenta Sociedade Tecnica Farmaceutica S.A.
Responsible authority:
- Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
- UP/I-322-05/17-01/39
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Croatian (PDF)
Published on: 20/02/2022