Ecomectin 10 mg/ml Solution for Injection
Ecomectin 10 mg/ml Solution for Injection
Authorised
- Ivermectin
Product identification
Medicine name:
Ecomectin 10 mg/ml Solution for Injection
Ecomectin 10 mg/ml Oplossing voor injectie
Ecomectin 10 mg/ml Solution injectable
Ecomectin 10 mg/ml Injektionslösung
Active substance:
- Ivermectin
Target species:
-
Cattle
-
Sheep
-
Pig
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Ivermectin10.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Subcutaneous use
- Cattle
-
Meat and offal42day
-
- Sheep
-
Meat and offal42day
-
- Pig
-
Meat and offal28day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP54AA01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Clear PET multidose container with bromobutyl rubber stopper and aluminium cap. Pack size 50 ml
- HDPE multidose container with bromobutyl rubber stopper and aluminium cap.Pack size: 200 ml.
- Clear PET multidose container with bromobutyl rubber stopper and aluminium cap. Pack size 500 ml
- HDPE multidose container with bromobutyl rubber stopper and aluminium cap.Pack size: 500 ml.
- HDPE multidose container with bromobutyl rubber stopper and aluminium cap.Pack size: 50 ml.
- Clear PET multidose container with bromobutyl rubber stopper and aluminium cap. Pack size 250 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
- Eco Animal Health Europe Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Produlab Pharma B.V.
- Divasa Farmavic S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V261091
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0144/001
Concerned member states:
-
Austria
-
Belgium
-
Estonia
-
France
-
Germany
-
Greece
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Netherlands
-
Portugal
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Labelling
This document does not exist in this language (English). You can find it in another language below.
How useful was this page?: