Veterinary Medicines

AGALAX TRES SUSPENSION INYECTABLE

Authorised
  • Mycoplasma agalactiae, strain N84, Inactivated
  • Mycoplasma capricolum, strain 27343, Inactivated
  • Mycoplasma mycoides, subsp. mycoides, strain HH, Inactivated
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Product identification

Medicine name:
AGALAX TRES SUSPENSION INYECTABLE
Active substance:
  • Mycoplasma agalactiae, strain N84, Inactivated
  • Mycoplasma capricolum, strain 27343, Inactivated
  • Mycoplasma mycoides, subsp. mycoides, strain HH, Inactivated
Target species:
  • Sheep
  • Goat
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Mycoplasma agalactiae, strain N84, Inactivated
    20.00
    antibody unit(s)
    /
    1.00
    Dose
  • Mycoplasma capricolum, strain 27343, Inactivated
    20.00
    antibody unit(s)
    /
    1.00
    Dose
  • Mycoplasma mycoides, subsp. mycoides, strain HH, Inactivated
    20.00
    antibody unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
      • Meat and offal
        0
        day
    • Goat
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI04AB
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) 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:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2568 ESP
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 8/08/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 8/08/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 29/11/2023
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