Dectomax Inspuitbare Oplossing 10 mg/ml Oplossing voor injectie
Dectomax Inspuitbare Oplossing 10 mg/ml Oplossing voor injectie
Not authorised
- Doramectin
Product identification
Medicine name:
Dectomax Inspuitbare Oplossing 10 mg/ml Oplossing voor injectie
Active substance:
- Doramectin
Target species:
-
Sheep
-
Cattle
Route of administration:
-
Intramuscular use
-
Subcutaneous use
Product details
Active substance and strength:
-
Doramectin10.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Sheep
-
Meat and offal70day·
-
Milkno withdrawal periodNot permitted for use in lactating animals producing milk for human consumption. Do not use in pregnant ewes, which are intended to produce milk for human consumption, within 70 days of expected parturition.
-
-
-
Subcutaneous use
-
Cattle
-
Milkno withdrawal periodNot permitted for use in lactating animals producing milk for human consumption. Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
-
Meat and offal70day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP54AA03
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Surrendered
Authorised in:
-
Belgium
Package description:
- Dectomax Solution for Injection 250 ml Vial Solution for injection
- Dectomax Solution for Injection 500 ml Vial Solution for injection
- Dectomax Solution for Injection 200 ml Vial Solution for injection
- Dectomax Solution for 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:
- Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- Elanco France S.A.S.
- Norbrook Laboratories Limited
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V172365
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
This document does not exist in this language (English). You can find it
in another language below.
Package Leaflet
This document does not exist in this language (English). You can find it
in another language below.
