Veterinary Medicines

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

Authorised
  • Cyanocobalamin
  • Butafosfan
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Product identification

Medicine name:
Ralcam, 100+0,05mg/ml, Solution for injection
Catobevit 100 mg/ml + 0.05 mg/ml Injektionslösung für Rinder
Active substance:
  • Cyanocobalamin
  • Butafosfan
Target species:
  • Cattle
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Cyanocobalamin
    0.05
    milligram(s)
    /
    1.00
    millilitre(s)
  • Butafosfan
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA12CX99
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
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:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • TAD Pharma GmbH
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 402646.00.00
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0160/001
Concerned member states:
  • Germany

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (RTF)
Published on: 3/01/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (RTF)
Published on: 3/01/2025
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