Veterinary Medicines

GUDAIR Emulsion for injection for sheep and goats

Authorised
  • Mycobacterium avium, subsp. paratuberculosis, strain 316F, Inactivated
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Product identification

Medicine name:
GUDAIR Emulsion for injection for sheep and goats
Gudair injeksjonsvæske, emulsjon for sau og geit.
Active substance:
  • Mycobacterium avium, subsp. paratuberculosis, strain 316F, Inactivated
Target species:
  • Sheep
  • Goat
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Mycobacterium avium, subsp. paratuberculosis, strain 316F, Inactivated
    2.00
    tuberculin unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
      • Meat and offal
        0
        day
    • Goat
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI03AB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Available in:
  • Norway
Package description:
  • box containing 1 vial of 30 ml (30 doses)

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:
  • CZ Vaccines S.A.U.
Marketing authorisation date:
Manufacturing sites for batch release:
  • CZ Vaccines S.A.U.
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 13-9626
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0210/001
Concerned member states:
  • France
  • Iceland
  • Norway
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/04/2023
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Norwegian (PDF)
Published on: 18/03/2024
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Package Leaflet

English (PDF)
Published on: 27/06/2024
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Norwegian (PDF)
Published on: 18/03/2024
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Labelling

English (PDF)
Published on: 27/06/2024
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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