Veterinary Medicines

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

Authorised
  • Moxidectin
Download as PDF

Product identification

Medicine name:
AFILARIA SR 3.4 mg/ml powder and solvent for suspension for injection for dogs
AFILARIA SR 3,4 mg/mL, prašak i otapalo za suspenziju za injekciju, za pse
Active substance:
  • Moxidectin
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Moxidectin
    100.00
    milligram(s)/gram
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder and solvent for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Available in:
  • Croatia
Package description:

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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/22-01/149
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0315/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Czechia
  • France
  • Greece
  • Hungary
  • Italy
  • Portugal
  • Romania
  • Slovakia
  • Slovenia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
Download

Package Leaflet

English (PDF)
Published on: 12/04/2023
Download

Labelling

English (PDF)
Published on: 12/04/2023
Download

eu-PUAR-afilaria-sr-3.4-mg-ml-powder-and-solvent-for-suspension-for-injection-for-dogs-en.pdf

English (PDF)
Published on: 12/04/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."