Product identification
Medicine name:
Fatromectin 5 mg/ml pour-on solution for cattle.
QUALIMEC POUR-ON
Active substance:
- Ivermectin
Target species:
-
Cattle
Route of administration:
-
Topical use
Product details
Active substance and strength:
-
Ivermectin5.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Pour-on solution
Withdrawal period by route of administration:
-
Topical use
- Cattle
-
Meat and offal31day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP54AA01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription except for some pack sizes
Authorisation status:
-
Valid
Package description:
- 5.0 L white non-fluorinated or fluorinated high-density polyethylene back-pack with polypropylene strap and vented cap Closure: White polypropylene screw-cap
- 2.5 L white non-fluorinated or fluorinated high-density polyethylene back-pack with polypropylene strap and vented cap Closure: White polypropylene screw-cap
- 1.0 L white non-fluorinated or fluorinated high-density polyethylene bottle with a drawing tube and measuring device. Closure: White polypropylene screw-cap
- 250 ml white non-fluorinated or fluorinated high-density polyethylene bottle with a drawing tube and measuring device. Closure: White polypropylene screw-cap
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Well-established use application (Article 13a of Directive No 2001/82/EC)
Manufacturing sites for batch release:
- Acme Drugs - S.r.l.
- Safapac (Cambridge) Limited
Authorisation number:
- FR/V/7879631 9/2006
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0177/001
Concerned member states:
-
France
-
Italy
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 11/02/2022
French (PDF)
Published on: 17/11/2023