Santiola 50 mg/ml solution for injection for cattle and sheep
Santiola 50 mg/ml solution for injection for cattle and sheep
Not authorised
- Closantel sodium dihydrate
Product identification
Medicine name:
Santiola 50 mg/ml solution for injection for cattle and sheep
Santiola 50 mg/ml raztopina za injiciranje za govedo in ovce
Active substance:
- Closantel sodium dihydrate
Target species:
-
Cattle
-
Sheep
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Closantel sodium dihydrate54.38/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Subcutaneous use
- Cattle
-
Meat and offal77day
-
- Sheep
-
Meat and offal107day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP52AG09
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Surrendered
Authorised in:
-
Slovenia
Package description:
- Container or pack size: 4 type I amber glass vials. Closure: bromobutyl rubber. Contents of each vial: 250 ml solution.
- Container or pack size: 1 type I amber glass vial. Closure: bromobutyl rubber. Contents of each vial: 250 ml solution.
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:
- KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
- Krka d.d. Novo Mesto
- Tad Pharma GmbH
Responsible authority:
- Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
- DC/V/0595/001
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0377/001
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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