Product identification
Medicine name:
Qualimec 10 mg/ml Solution for Injection.
Ivermax 10 mg/ml oplossing voor injectie
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 offal49day
-
- 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
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)
Manufacturing sites for batch release:
- Produlab Pharma B.V.
- Divasa Farmavic S.A.
Authorisation number:
- REG NL 10446
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0145/001
Concerned member states:
-
France
-
Germany
-
Greece
-
Hungary
-
Italy
-
Luxembourg
-
Netherlands
-
Portugal
-
Spain
-
United Kingdom (Northern Ireland)
Documents
Combined File of all Documents
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Dutch (PDF)
Published on: 27/12/2023
Summary of Product Characteristics
English (PDF)
Download Published on: 11/02/2022