Veterinary Medicines

MARBOSYVA 100 mg/ml solution for injection for cattle and pigs.

Authorised
  • Marbofloxacin
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Product identification

Medicine name:
MARBOSYVA 100 mg/ml solution for injection for cattle and pigs.
Marbosyva 100 mg/ml solução injectável para bovinos e suínos (porcas)
Active substance:
  • Marbofloxacin
Target species:
  • Cattle
  • Pig (female)
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Marbofloxacin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig (female)
      • Meat and offal
        4
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
  • Subcutaneous use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA93
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Available in:
  • Portugal
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.U.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 625/01/12DFVPT
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)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 24/06/2022
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Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
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Package Leaflet

English (PDF)
Published on: 22/12/2023
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Labelling

English (PDF)
Published on: 22/12/2023
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eu-PUAR-esv0188001-dcp-marbosyva-100-mg-ml-solution-for-injection-for-cattle-and-pigs.-en.pdf

English (PDF)
Published on: 22/12/2023
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