Veterinary Medicines

AD live-SUIVAX

Authorised
  • Aujeszky's disease virus, strain LomBart, Live
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Product identification

Medicine name:
AD live-SUIVAX
AD live-SUIVAX
Active substance:
  • Aujeszky's disease virus, strain LomBart, Live
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Aujeszky's disease virus, strain LomBart, Live
    6.50
    log10 cell culture infective dose 50
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AD01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • Cardboard box containing 10 glass vials of 50 doses of vaccine sealed with rubber cap and aluminum ring with rubber cap and aluminum ring + 10 glass or polypropylene vials of 100 ml of glass or polypropylene bottles of 100 ml of diluent with elastomer cap and aluminum ring.
  • Cardboard box containing 10 glass vials of 10 doses of vaccine sealed with rubber stopper and aluminum ring + 10 glass or polypropylene vials of 20 ml of diluent with elastomer stopper and aluminum ring.
  • Cardboard box containing 50 doses glass vial of sealed vaccine with rubber stopper and aluminum ring + 100 ml vial or polypropylene bottle of diluent with elastomer stopper and aluminum ring.
  • Cardboard box containing 10 doses glass vial of sealed vaccine with rubber stopper and aluminum ring + 1 20 ml glass or polypropylene vial of diluent with elastomer stopper and aluminum ring.

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:
  • Ministry Of Health
Authorisation number:
  • 102412
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0109/001
Concerned member states:
  • Portugal
  • Spain

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 2/03/2022
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