MARBOSYVA 100 mg/ml solution for injection for cattle and pigs.
MARBOSYVA 100 mg/ml solution for injection for cattle and pigs.
Authorised
- Marbofloxacin
Product identification
Medicine name:
MARBOSYVA 100 mg/ml solution for injection for cattle and pigs.
Marbosyva 100 mg/ml oldatos injekció szarvasmarhák és sertések részére A.U.V.
Active substance:
- Marbofloxacin
Target species:
-
Cattle
-
Pig (female)
Route of administration:
-
Intramuscular use
-
Intravenous use
-
Subcutaneous use
Product details
Active substance and strength:
-
Marbofloxacin100.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle
-
Meat and offalno withdrawal periodMeat and offal: Intramuscular use (8 mg/kg single dose): 3 days / Intramuscular or subcutaneous use (2 mg/kg single daily injection, for 3-5 days): 6 days
-
-
Pig (female)
-
Meat and offal4day
-
-
Cattle
-
Milkno withdrawal periodMilk: IM (single dose) 72 hours / IM or SC 36 Hours
-
-
-
Intravenous use
-
Cattle
-
Meat and offalno withdrawal periodMeat and offal: Intramuscular use (8 mg/kg single dose): 3 days / Intramuscular or subcutaneous use (2 mg/kg single daily injection, for 3-5 days): 6 days
-
-
Cattle
-
Milkno withdrawal periodMilk: IM (single dose) 72 hours / IM or SC 36 Hours
-
-
-
Subcutaneous use
-
Cattle
-
Meat and offalno withdrawal periodMeat and offal: Intramuscular use (8 mg/kg single dose): 3 days / Intramuscular or subcutaneous use (2 mg/kg single daily injection, for 3-5 days): 6 days
-
-
Cattle
-
Milkno withdrawal periodMilk: IM (single dose) 72 hours / IM or SC 36 Hours
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01MA93
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Hungary
Available in:
-
Hungary
Package description:
- cardboard box containing 1 vial of 250 ml
- cardboard box containing 1 vial of 100 ml
- cardboard box containing 1 vial of 50 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:
- Laboratorios Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Laboratorios Syva S.A.
Responsible authority:
- Directorate Of Veterinary Medicinal Products
Authorisation number:
- 3268/X/12 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0188/001
Concerned member states:
-
Austria
-
Bulgaria
-
Germany
-
Hungary
-
Ireland
-
Italy
-
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-esv0188001-dcp-marbosyva-100-mg-ml-solution-for-injection-for-cattle-and-pigs.-en.pdf
English (PDF)
Download Published on: 22/12/2023
