Veterinary Medicines

AGALAX UNO SUSPENSION INYECTABLE PARA OVINO Y CAPRINO

Authorised
  • Mycoplasma agalactiae, strain N84, Inactivated
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Product identification

Medicine name:
AGALAX UNO SUSPENSION INYECTABLE PARA OVINO Y CAPRINO
Active substance:
  • Mycoplasma agalactiae, strain N84, Inactivated
Target species:
  • Sheep
  • Goat
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Mycoplasma agalactiae, strain N84, Inactivated
    4.23
    enzyme-linked immunosorbent assay unit
    /
    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.U.
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2567 ESP
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Spanish (PDF)
Published on: 1/02/2024
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Package Leaflet

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Spanish (PDF)
Published on: 1/02/2024
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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: 1/02/2024
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