Doraxx 100 mg/ml solution for injection for cattle, pigs and sheep
Doraxx 100 mg/ml solution for injection for cattle, pigs and sheep
Authorised
- Tulathromycin
Product identification
Medicine name:
Doraxx 100 mg/ml solution for injection for cattle, pigs and sheep
Doraxx 100 mg/ml injektionsvæske, opløsning
Active substance:
- Tulathromycin
Target species:
-
Cattle
-
Pig
-
Sheep
Route of administration:
-
Subcutaneous use
-
Intramuscular use
Product details
Active substance and strength:
-
Tulathromycin100.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Subcutaneous use
- Cattle
-
Meat and offal22day
-
Milkno withdrawal periodMeat and offal: 22 days; Not authorised for use in animals producing milk for human consumption. Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition
-
-
Intramuscular use
- Pig
-
Meat and offal13day
-
- Sheep
-
Milkno withdrawal periodMeat and offal: 16 days; Milk: Not authorised for use in animals producing milk for human consumption. Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition
-
Meat and offal16day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01FA94
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Denmark
Package description:
- Cardboard box with 1 vial of 250 ml
- Cardboard box with 1 vial of 100 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Mevet S.A.U.
- Dopharma B.V.
Responsible authority:
- Danish Medicines Agency
Authorisation number:
- 64263
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0390/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Denmark
-
Estonia
-
France
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
eu-PUAR-doraxx-100-mg-ml-solution-for-injection-for-cattle--pigs-and-sheep-en.pdf
English (PDF)
Download Published on: 12/04/2023
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