Veterinary Medicines

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

Authorised
  • Moxidectin
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Product identification

Medicine name:
AFILARIA LIBERACION PROLONGADA 3,4 mg/ml POLVO Y DISOLVENTE PARA SUSPENSION INYECTABLE PARA PERROS
AFILARIA SR 3.4 mg/ml powder and solvent for suspension for injection for dogs
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:
  • Spain
Available in:
  • Spain
Package description:
  • Cardboard box with 1 powder vial containing 197,3 mg, 1 solvent vial with 5,67 ml and 1 adapter for reconstitution and withdrawal, 1 syringe and 1 needle.
  • Cardboard box with 1 powder vial containing 197,3 mg, 1 solvent vial with 5,67 ml and 1 adapter for reconstitution and withdrawal.
  • Cardboard box with 1 powder vial containing 592 mg, 1 solvent vial with 17 ml and 1 adapter for reconstitution and withdrawal, 1 syringe and 1 needle.
  • Cardboard box with 1 powder vial containing 592 mg, 1 solvent vial with 17 ml and 1 adapter for reconstitution and withdrawal.

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:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3807 ESP
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
Spanish (PDF)
Published on: 17/03/2023
Download

Package Leaflet

English (PDF)
Published on: 12/04/2023
Download
Spanish (PDF)
Published on: 17/03/2023
Download

Labelling

English (PDF)
Published on: 12/04/2023
Download
Spanish (PDF)
Published on: 17/03/2023
Download

Combined File of all Documents

English (PDF)
Published on: 21/11/2022
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

es-puar-afilaria-sr-3.4-mg-ml-powder-and-solvent-for-suspension-for-injection-for-dogs-es.pdf

Spanish (PDF)
Published on: 17/03/2023
Download
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