Veterinary Medicines

CALIERCORTIN 4 mg/ml solution for injection for cattle, pigs, horses, dogs and cats

Authorised
  • Dexamethasone sodium phosphate
Download as PDF

Product identification

Medicine name:
CALIERCORTIN 4 mg/mL, otopina za injekciju, za goveda, svinje, konje, pse i mačke
CALIERCORTIN 4 mg/ml solution for injection for cattle, pigs, horses, dogs and cats
Active substance:
  • Dexamethasone sodium phosphate
Target species:
  • Cattle
  • Dog
  • Horse
  • Cat
  • Pig
Route of administration:
  • Intravenous use
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Dexamethasone sodium phosphate
    5.30
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Milk
        4
        day
      • Meat and offal
        16
        day
    • Horse
      • Meat and offal
        16
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        4
        day
  • Subcutaneous use
    • Cattle
      • Milk
        4
        day
      • Meat and offal
        16
        day
    • Horse
      • Meat and offal
        16
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        4
        day
  • Intramuscular use
    • Cattle
      • Milk
        4
        day
      • Meat and offal
        16
        day
    • Horse
      • Meat and offal
        16
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        4
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Package description:
  • (ID2): 1 unspecified outer container with 1 Vial (Glass) with 50 millilitre(s) (50 millilitre(s))
  • (ID1): 1 unspecified outer container with 1 Vial (Glass) with 10 millilitre(s) (10 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:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/19-01/480
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0179/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Cyprus
  • Greece
  • Italy
  • Poland
  • Portugal
  • Romania
  • Spain

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Croatian (PDF)
Published on: 20/03/2023
Download