Veterinary Medicines

GUARDIAN SR 3.4 mg/ml powder and solvent for suspension for injection for dogs

Authorised
  • Moxidectin
Download as PDF

Product identification

Medicine name:
GUARDIAN SR 3.4 mg/ml powder and solvent for suspension for injection for dogs
GUARDIAN SR 3,4 mg/ml polvere e solvente per sospensione iniettabile per cani
Active substance:
  • Moxidectin
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Moxidectin
    10.00
    gram(s)
    /
    100.00
    gram(s)
Pharmaceutical form:
  • Powder and solvent for suspension for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Available in:
  • Italy
Package description:
  • Type I glass vial of 20 ml containing not less than 538 mg of moxidectin microsphere (equal to 59.2 mg of moxidectin) and type I glass vial of 28.5 ml containing not less than 17 ml of vehicle

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 GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Elanco France S.A.S
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 103186
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0111/001
Concerned member states:
  • France
  • Greece
  • Portugal
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 25/09/2023
Updated on: 26/09/2023
Download
Italian (PDF)
Published on: 3/10/2023
Download