Veterinary Medicines

Gallimune 201 IBD + REO Emulsja do wstrzykiwań

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

Medicine name:
Gallimune 201 IBD + REO Emulsja do wstrzykiwań
Active substance:
  • Infectious bursal disease virus, strain VNJO, Inactivated
  • Avian reovirus, strain S1133, Live
Target species:
  • Chicken (hen)
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Infectious bursal disease virus, strain VNJO, Inactivated
    9.00
    enzyme-linked immunosorbent assay unit
    /
    1.00
    enzyme-linked immunosorbent assay unit
  • Avian reovirus, strain S1133, Live
    9.00
    enzyme-linked immunosorbent assay unit
    /
    1.00
    enzyme-linked immunosorbent assay unit
Pharmaceutical form:
  • Emulsion for injection/infusion
Withdrawal period by route of administration:
  • Intramuscular use
    • Chicken (hen)
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Chicken (hen)
      • Meat and offal
        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:
  • Poland
Available in:
  • Poland
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:
  • Merial Italia S.p.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1283
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.
Polish (PDF)
Published on: 6/02/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 6/02/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 6/02/2023
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