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OVALAXIA ενέσιμο εναιώρημα για πρόβατα

Authorised
  • Mycoplasma agalactiae, strain AG 8, Inactivated
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Product identification

Medicine name:
OVALAXIA ενέσιμο εναιώρημα για πρόβατα
Active substance:
  • Mycoplasma agalactiae, strain AG 8, Inactivated
Target species:
  • Sheep
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Mycoplasma agalactiae, strain AG 8, Inactivated
    9.00
    log10 colour changing units
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
      • 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:
  • Greece
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • National Organization For Medicines
Authorisation number:
  • 15840/13-02-2025/K-0213301
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Greek (PDF)
Published on: 6/03/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Greek (PDF)
Published on: 6/03/2025
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