TILMI-kel 300 mg/ml solution for injection for cattle
TILMI-kel 300 mg/ml solution for injection for cattle
Not authorised
- Tilmicosin
Product identification
Medicine name:
TILMI-kel 300 mg/ml solution for injection for cattle
Tilmi-Kel 300 mg/ml Oplossing voor injectie voor runderen en schapen
Tilmi-Kel 300 mg/ml Solution injectable pour bovins et ovins
Tilmi-Kel 300 mg/ml Injektionslösung für Rinder und Schafe
Active substance:
- Tilmicosin
Target species:
-
Sheep
-
Cattle
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Tilmicosin300.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Subcutaneous use
-
Sheep
-
Meat and offal42day
-
Milk18day
-
-
Cattle
-
Meat and offal70day
-
Milk36day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01FA91
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Surrendered
Authorised in:
-
Belgium
Package description:
- box containing 12 vials of 250 ml
- box containing 12 vials of 100 ml
- box containing 12 vials of 50 ml
- box containing 10 vials of 250 ml
- box containing 10 vials of 100 ml
- box containing 10 vials of 50 ml
- box containing 6 vials of 250 ml
- box containing 6 vials of 100 ml
- box containing 6 vials of 50 ml
- box containing 1 vial of 250 ml
- box containing 1 vial of 100 ml
- box containing 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:
- Kela Kempisch Laboratorium Kela Laboratoria
Marketing authorisation date:
Manufacturing sites for batch release:
- Industrial Veterinaria S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V346665
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0144/001
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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