Veterinary Medicines

GALLIMUNE 201 IBD+Reo injekčná emulzia pre kurčatá

Authorised
  • Avian reovirus, strain S1133, Live
  • Infectious bursal disease virus, strain VNJO, Inactivated
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Product identification

Medicine name:
GALLIMUNE 201 IBD+Reo injekčná emulzia pre kurčatá
Active substance:
  • Avian reovirus, strain S1133, Live
  • Infectious bursal disease virus, strain VNJO, Inactivated
Target species:
  • Chicken (for reproduction)
  • Chicken (layer hen)
Route of administration:
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Avian reovirus, strain S1133, Live
    9.00
    enzyme-linked immunosorbent assay unit
    /
    0.30
    millilitre(s)
  • Infectious bursal disease virus, strain VNJO, Inactivated
    9.00
    enzyme-linked immunosorbent assay unit
    /
    0.30
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Chicken (for reproduction)
      • All relevant tissues
        0
        day
    • Chicken (layer hen)
      • All relevant tissues
        0
        day
  • Intramuscular use
    • Chicken (for reproduction)
      • All relevant tissues
        0
        day
    • Chicken (layer hen)
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AA22
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
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:
  • Boehringer Ingelheim Animal Health Italia S.p.A. In Breve Boehringer Ingelheim Ah It S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health Italia S.p.A. In Breve Boehringer Ingelheim Ah It S.p.A.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/012/00-S
Date of authorisation status change:

Documents

Combined File of all Documents

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Slovak (PDF)
Published on: 16/08/2023
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