MITEX
MITEX
Authorised
- Miconazole nitrate
- POLYMYXIN B SULFATE
- Prednisolone acetate
Product identification
Medicine name:
MITEX
Active substance:
- Miconazole nitrate
- POLYMYXIN B SULFATE
- Prednisolone acetate
Target species:
-
Dog
-
Cat
Route of administration:
-
Auricular use
Product details
Active substance and strength:
-
Miconazole nitrate23.00/milligram(s)1.00gram(s)
-
POLYMYXIN B SULFATE5500.00/international unit(s)1.00gram(s)
-
Prednisolone acetate5.00/milligram(s)1.00gram(s)
Pharmaceutical form:
-
Ear drops, suspension
Withdrawal period by route of administration:
-
Auricular use
-
Dog
-
Cat
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QS02CA01
Legal status of supply:
This information is not available for this product.
Authorisation status:
-
Valid
Authorised in:
-
Romania
Package description:
- Available only in Romanian
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Complete application (stand-alone) - Directive No 2001/82/EC
Marketing authorisation holder:
- Vetviva Richter GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- Vetviva Richter GmbH
Responsible authority:
- Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
- 230037
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
This document does not exist in this language (English). You can find it
in another language below.
Romanian (PDF)
Published on: 13/07/2023
Updated on: 18/07/2023
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