Veterinary Medicines

Santiola 50 mg/ml solution for injection for cattle and sheep

Not authorised
  • Closantel sodium dihydrate
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Product identification

Medicine name:
Santiola 50 mg/ml solution for injection for cattle and sheep
Santiola, 50 mg/mL, otopina za injekciju, za goveda i ovce
Active substance:
  • Closantel sodium dihydrate
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Closantel sodium dihydrate
    54.38
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        77
        day
    • Sheep
      • Meat and offal
        107
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AG09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Croatia
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 tovarna zdravil d.d. Novo mesto
  • TAD Pharma GmbH
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/18-01/104
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0377/001

Documents

Summary of Product Characteristics

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Croatian (PDF)
Published on: 30/03/2022
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