Veterinary Medicines

Catosal 100 mg/ml + 0.05 mg/ml solution for injection for cattle, horses and dogs

Authorised
  • Butafosfan
  • Cyanocobalamin
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Product identification

Medicine name:
CATOSAL 100 mg/ml + 0,05 mg/ml
Catosal 100 mg/ml + 0.05 mg/ml solution for injection for cattle, horses and dogs
Active substance:
  • Butafosfan
  • Cyanocobalamin
Target species:
  • Cattle
  • Dog
  • Horse
Route of administration:
  • Intravenous use
  • Intramuscular 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:
  • Intravenous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA12CX99
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • (ID2) 250 millilitre(s): Box (Cardboard) with 1 Vial (Glass type I) with 250 millilitre(s), closed with Stopper and Cap and Stopper and Cap (chlorobutyl rubber`, Aluminium, chlorobutyl rubber`, Aluminium)
  • (ID1) 100 millilitre(s): Box (Cardboard) with 1 Vial (Glass type II) with 100 millilitre(s), closed with Stopper and Cap and Cap and Stopper (chlorobutyl rubber`, Aluminium, Aluminium, chlorobutyl rubber`)
  • (ID3) 50 millilitre(s): Box (Cardboard) with 1 Vial (Glass type II) with 50 millilitre(s), closed with Stopper and Cap (chlorobutyl rubber`, Aluminium)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis reviewed according to Acquis communautaire
Marketing authorisation holder:
  • Elanco Animal Health GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • KVP Pharma+Veterinaer Produkte GmbH
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 110193
Date of authorisation status change:

Documents

Combined File of all Documents

English (PDF)
Published on: 5/12/2024
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Romanian (PDF)
Published on: 31/07/2024
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