AFILARIA SR 3.4 mg/ml powder and solvent for suspension for injection for dogs
AFILARIA SR 3.4 mg/ml powder and solvent for suspension for injection for dogs
Authorised
- Moxidectin
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 POUDRE ET SOLVANT POUR SUSPENSION INJECTABLE POUR CHIENS
Active substance:
- Moxidectin
Target species:
-
Dog
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Moxidectin100.00milligram(s)/gram1.00gram(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:
-
France
Available in:
-
France
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:
- National Veterinary Medicines Agency
Authorisation number:
- FR/V/7888595 0/2019
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
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet and Labelling
This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 8/12/2022
Summary of Product Characteristics
English (PDF)
Download Published on: 12/04/2023
French (PDF)
Published on: 4/05/2023
Package Leaflet
English (PDF)
Download Published on: 12/04/2023
eu-PUAR-afilaria-sr-3.4-mg-ml-powder-and-solvent-for-suspension-for-injection-for-dogs-en.pdf
English (PDF)
Download Published on: 12/04/2023
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