LABIXXIN 100MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP
LABIXXIN 100MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP
Authorised
- Tulathromycin
Product identification
Medicine name:
LABIXXIN 100MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP
LABIXXIN 100 mg/ml SOLUCIÓN INYECTABLE PARA BOVINO, PORCINO Y OVINO
Active substance:
- Tulathromycin
Target species:
-
Pig
-
Sheep
-
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
-
Pig
-
Meat and offal13day
-
-
Sheep
-
Meat and offal16day
-
-
Sheep
-
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.
-
-
-
Subcutaneous use
-
Cattle
-
Meat and offal22day
-
-
Cattle
-
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:
-
Spain
Available in:
-
Spain
Package description:
- Cardboard box containing 1 vial of 250 ml
- Cardboard box containing 1 vial of 100 ml
- Cardboard box containing 1 vial of 50 ml
- Cardboard box containing 1 vial of 20 ml
- Cardboard box containing 10 vials of 250 ml
- Cardboard box containing 10 vials of 100 ml
- Cardboard box containing 12 vials of 50 ml
- Cardboard box containing 12 vials of 20 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Labiana Life Sciences S.A.
Responsible authority:
- Spanish Agency Of Medicines And Medical Devices
Authorisation number:
- 4243 ESP
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0423/001
Concerned member states:
-
Croatia
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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in another language below.
Spanish (PDF)
Published on: 21/10/2024
