MITЕХ Eardrops for dogs and cats
MITЕХ Eardrops for dogs and cats
Not authorised
- Miconazole nitrate
- Prednisolone acetate
- POLYMYXIN B SULFATE
Product identification
Medicine name:
МИТЕКС капки за уши за кучета и котки
MITЕХ Eardrops for dogs and cats
Active substance:
- Miconazole nitrate
- Prednisolone acetate
- POLYMYXIN B SULFATE
Target species:
-
Dog
-
Cat
Route of administration:
-
Auricular use
Product details
Active substance and strength:
-
Miconazole nitrate23.00/milligram(s)1.00gram(s)
-
Prednisolone acetate5.00/milligram(s)1.00gram(s)
-
POLYMYXIN B SULFATE5500.00/international unit(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:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Surrendered
Authorised in:
-
Bulgaria
Package description:
- Available only in Bulgarian
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Vetviva Richter GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- Richter Pharma AG
Responsible authority:
- Bulgarian Agency For Food Safety
Authorisation number:
- 0022-1446
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.
Bulgarian (PDF)
Published on: 30/03/2023
Package Leaflet and Labelling
This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 30/03/2023
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