Veterinary Medicines

BYEMITE 500 MG/ML CONCENTRATE FOR SPRAYING EMULSION FOR LAYING HENS

Authorised
  • Phoxim
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Product identification

Medicine name:
BYEMITE 500 MG/ML CONCENTRATE FOR SPRAYING EMULSION FOR LAYING HENS
ByeMite 500 mg/ml концентрат за спрей-емулсия за кокошки носачки
Active substance:
  • Phoxim
Target species:
  • Chicken (layer hen)
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Phoxim
    500.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Concentrate for spray emulsion
Withdrawal period by route of administration:
  • Cutaneous use
    • Chicken (layer hen)
      • Meat and offal
        25
        day
      • Eggs
        12
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AF01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
Package description:
  • Bottle of 250 mL
  • Bottle of 5 L
  • Bottle of 1 L

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Elanco Animal Health GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • KVP Pharma+Veterinaer Produkte GmbH
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2127
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0196/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Finland
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden

Documents

Summary of Product Characteristics

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Bulgarian (PDF)
Published on: 3/10/2025
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Package Leaflet

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Bulgarian (PDF)
Published on: 3/10/2025
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Labelling

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Bulgarian (PDF)
Published on: 3/10/2025
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