MACROSYN 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP
MACROSYN 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP
Authorised
- Tulathromycin
Product identification
Medicine name:
MACROSYN 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP
Macrosyn 100 mg/ml Oplossing voor injectie
Macrosyn 100 mg/ml Solution injectable
Macrosyn 100 mg/ml Injektionslösung
Active substance:
- Tulathromycin
Target species:
-
Sheep
-
Pig
-
Cattle
Route of administration:
-
Intramuscular use
-
Subcutaneous use
Product details
Active substance and strength:
-
Tulathromycin100.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Sheep
-
Meat and offal16day
-
Milkno withdrawal periodNot authorised for use in animals producing milk for human consumption.
Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
-
-
Pig
-
Meat and offal13day
-
-
-
Subcutaneous use
-
Cattle
-
Meat and offal22day
-
Milkno withdrawal periodNot authorised for use in animals producing milk for human consumption.
Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01FA94
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Bimeda Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Bimeda Animal Health Limited
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V571146
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0418/001
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
Estonia
-
Germany
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Poland
-
Spain
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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