Veterinary Medicines

AGALAX-S

Authorised
  • Mycoplasma agalactiae, Inactivated
  • Mycoplasma capricolum, Inactivated
  • Mycoplasma mycoides subsp. mycoides, Inactivated
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Product identification

Medicine name:
Агалакс С
AGALAX-S
Active substance:
  • Mycoplasma agalactiae, Inactivated
  • Mycoplasma capricolum, Inactivated
  • Mycoplasma mycoides subsp. mycoides, Inactivated
Target species:
  • Sheep
  • Goat
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Mycoplasma agalactiae, Inactivated
    10.00
    log10 colony forming unit(s)
    /
    2.00
    millilitre(s)
  • Mycoplasma capricolum, Inactivated
    10.00
    log10 colony forming unit(s)
    /
    2.00
    millilitre(s)
  • Mycoplasma mycoides subsp. mycoides, Inactivated
    10.00
    log10 colony forming unit(s)
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
    • Goat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI03AB
  • QI04AB
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
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:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-1804
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.
Bulgarian (PDF)
Published on: 30/01/2024
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 30/01/2024
Download
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