Veterinary Medicines

Marbodug 100 mg/ml Solution for Injection for Cattle and Pigs

Authorised
  • Marbofloxacin
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Product identification

Medicine name:
Marbodug 100 mg/ml Solution for Injection for Cattle and Pigs
ODIMAR 100 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO
Active substance:
  • Marbofloxacin
Target species:
  • Cattle
  • Pig
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
        3
        day
      • Meat and offal
        6
        day
      • Milk
        36
        hour
      • Milk
        72
        hour
    • Pig
      • Meat and offal
        4
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        6
        day
      • Milk
        36
        hour
  • Subcutaneous use
    • Cattle
      • Meat and offal
        6
        day
      • Milk
        36
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA93
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • Packaged in Amber type II glass vial of 10ml.Vial is closed with a fluorinated bromobutyl rubber stopper oversealed with an aluminium cap. Each vial is packaged in a cardboard box.
  • Packaged in Amber type II glass vial of 20ml.Vial is closed with a fluorinated bromobutyl rubber stopper oversealed with an aluminium cap. Each vial is packaged in a cardboard box.
  • Packaged in Amber type II glass vial of 50ml.Vial is closed with a fluorinated bromobutyl rubber stopper oversealed with an aluminium cap. Each vial is packaged in a cardboard box.
  • Packaged in Amber type II glass vial of 100ml.Vial is closed with a fluorinated bromobutyl rubber stopper oversealed with an aluminium cap. Each vial is packaged in a cardboard box.
  • Packaged in Amber type II glass vial of 250ml.Vial is closed with a fluorinated bromobutyl rubber stopper oversealed with an aluminium cap. Each vial is packaged in a cardboard box.

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:
  • Emdoka
Marketing authorisation date:
Manufacturing sites for batch release:
  • PRODULAB PHARMA B.V.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 2720 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0457/002
Concerned member states:
  • Austria
  • Belgium
  • Germany
  • Luxembourg
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 15/12/2024
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Spanish (PDF)
Published on: 9/01/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 9/01/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 9/01/2025
Download

Combined File of all Documents

English (PDF)
Published on: 15/12/2024
Download
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