Ivermax 0,8 mg/ml mikstur, oppløsning til sau.
Ivermax 0,8 mg/ml mikstur, oppløsning til sau.
Authorised
- Ivermectin
Product identification
Medicine name:
Ivermax 0,8 mg/ml mikstur, oppløsning til sau.
Active substance:
- Ivermectin
Target species:
-
Sheep
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Ivermectin0.80/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Oral solution
Withdrawal period by route of administration:
-
Oral use
-
Sheep
-
Meat and offal10dayNot approved for animals that produce milk for human consumption. Pregnant animals that are to produce milk for human consumption must not be treated in the last 60 days before the expected birth.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP54AA01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Norway
Package description:
- Available only in Norwegian
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
- Norwegian Medical Products Agency
Authorisation number:
- 11-8473
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
English (PDF)
Download Published on: 29/12/2021
Norwegian (PDF)
Published on: 26/04/2022
