Veterinary Medicines

ROMPUN

Authorised
  • Xylazine
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Product identification

Medicine name:
ROMPUN
Active substance:
  • Xylazine
Target species:
  • Cattle
  • Dog
  • Cat
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Xylazine
    20.00
    milligram(s)
    /
    1.00
    milligram(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        24
        hour
      • Meat and offal
        24
        hour
  • Intravenous use
    • Cattle
      • Milk
        24
        hour
      • Meat and offal
        24
        hour
    • Horse
      • Meat and offal
        72
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM92
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Available in:
  • Italy
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Elanco Italia S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • KVP Pharma+Veterinaer Produkte GmbH
Responsible authority:
  • Ministry Of Health
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 30/09/2024
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