Veterinary Medicines

Catobevit, 100 + 0,05mg/ml, Solution for injection

Authorised
  • Butafosfan
  • Cyanocobalamin
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Product identification

Medicine name:
Catobevit, 100 + 0,05mg/ml, Solution for injection
Catobevit 100 mg/ml + 0,05 mg/ml Roztwór do wstrzykiwań
Active substance:
  • Butafosfan
  • Cyanocobalamin
Target species:
  • Dog
  • Cat
  • Cattle
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Butafosfan
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Cyanocobalamin
    0.05
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Cat
  • Intravenous use
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Horse
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Dog
    • Cat
  • Subcutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA12CX99
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • Glass Vial 1 x 250.0 millilitre(s)
  • Glass Vial 1 x 100.0 millilitre(s)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
  • TAD Pharma GmbH
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2850
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0145/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Estonia
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain

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: 4/02/2022
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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: 4/02/2022
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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: 4/02/2022
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