Veterinary Medicines

BelaZin, 20mg/ml, Solution for injection

Authorised
  • Xylazine
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Product identification

Medicine name:
BelaZin, 20mg/ml, Solution for injection
BelaZin, 20 mg/mL, otopina za injekciju, za goveda, konje, pse i mačke
Active substance:
  • Xylazine
Target species:
  • Cattle
  • Horse
  • Dog
  • Cat
Route of administration:
  • Intravenous use
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Xylazine
    20.00
    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
        1
        day
    • Horse
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
    • Dog
  • Intramuscular use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        1
        day
    • Dog
    • Cat
  • Subcutaneous use
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM92
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Package description:
  • Glass Vial 12 x 50.0 millilitre(s)
  • Glass Vial 1 x 50.0 millilitre(s)
  • Glass Vial 12 x 25.0 millilitre(s)
  • Glass Vial 10 x 25.0 millilitre(s)
  • Glass Vial 1 x 25.0 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:
  • Bela-Pharm GmbH & Co. KG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bela-Pharm GmbH & Co. KG
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/20-01/238
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0159/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Cyprus
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Portugal
  • Romania
  • Slovenia

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: 21/03/2022
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