Denagard 125 mg/ml Roztwór do podania w wodzie do picia
Denagard 125 mg/ml Roztwór do podania w wodzie do picia
Authorised
- Tiamulin hydrogen fumarate
Product identification
Medicine name:
Denagard 125 mg/ml Roztwór do podania w wodzie do picia
Active substance:
- Tiamulin hydrogen fumarate
Target species:
-
Pig
-
Chicken (hen)
-
Turkey
Route of administration:
-
In drinking water use
Product details
Active substance and strength:
-
Tiamulin hydrogen fumarate125.00milligram(s)1.00gram(s)
Pharmaceutical form:
-
Solution for use in drinking water
Withdrawal period by route of administration:
-
In drinking water use
- Pig
-
Meat and offal5week
-
- Chicken (hen)
-
Meat and offal5week
-
- Turkey
-
Meat and offal5week
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01XQ01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Poland
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:
- Elanco France S.A.S
- Argenta Dundee Limited
Responsible authority:
- Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
- 1385
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/05/2022
Labelling
This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/05/2022
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/05/2022
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