LABIMYCIN LA 300 mg/ml SOLUTION FOR INJECTION
LABIMYCIN LA 300 mg/ml SOLUTION FOR INJECTION
Authorised
- Oxytetracycline dihydrate
Product identification
Medicine name:
LABIMYCIN LA 300 mg/ml SOLUTION FOR INJECTION
Labimycin LA 300 mg/ml solution injectable
Labimycin LA 300 mg/ml oplossing voor injectie
Labimycin LA 300 mg/ml Injektionslösung
Active substance:
- Oxytetracycline dihydrate
Target species:
-
Pig
-
Cattle
-
Sheep
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Oxytetracycline dihydrate323.50milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Pig
-
Meat and offal28day
-
-
Cattle
-
Meat and offal35day
-
Milk7day
-
-
Sheep
-
Meat and offal35day
-
Milk9day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01AA06
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Box with 10 Vials of 250 ml
- Box with 10 Vials of 100 ml
- Box with 12 Vials of 50 ml
- Box with 1 vial of 250 ml
- Box with 1 vial of 100 ml
- Box with 1 Vial of 50 ml
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:
- Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- LABIANA LIFE SCIENCES, S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V663500
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0406/001
Concerned member states:
-
Belgium
-
Denmark
-
France
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Luxembourg
-
Netherlands
-
Portugal
-
Romania
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Labelling
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Package Leaflet
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