Noromectin Injection 10 mg/ml Oplossing voor injectie
Noromectin Injection 10 mg/ml Oplossing voor injectie
Authorised
- Ivermectin
Product identification
Medicine name:
Noromectin Injection 10 mg/ml Oplossing voor injectie
Noromectin Injection 10 mg/ml Solution injectable
Noromectin Injection 10 mg/ml Injektionslösung
Active substance:
- Ivermectin
Target species:
-
Pig
-
Cattle
-
Cattle (lactating cow)
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Ivermectin10.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Subcutaneous use
-
Pig
-
Meat and offal18day
-
-
Cattle
-
Milkno withdrawal periodNL - Niet gebruiken bij melkkoeien tijdens de lactatie, noch tijdens de droogstand wanneer de melk bestemd is voor humaan gebruik. Niet gebruiken bij vaarzen binnen 60 dagen voor het kalven. FR - Ne pas utiliser chez les vaches laitières pendant la lactation, ni pendant la période de tarissement quand le lait est destiné à un usage pour l’homme. Ne pas utiliser chez les génisses durant les 60 jours qui précèdent le vêlage.
-
Meat and offal49day
-
-
Cattle (lactating cow)
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP54AA01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- Noromectin Injection 1 l Vial Solution for injection
- Noromectin Injection 500 ml Vial Solution for injection
- Noromectin Injection 250 ml Vial Solution for injection
- Noromectin Injection 100 ml Vial Solution for injection
- Noromectin Injection 50 ml Vial Solution for injection
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:
- Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Norbrook Manufacturing Ltd
- Norbrook Laboratories Limited
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V241525
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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Labelling
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