Veterinary Medicines

Dexashot, 2mg/ml, Solution for injection

Authorised
  • Dexamethasone
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Product identification

Medicine name:
Dexashot, 2mg/ml, Solution for injection
DEXASHOT, 2 mg/mL, otopina za injekciju, za goveda, konje, svinje, pse i mačke
Active substance:
  • Dexamethasone
Target species:
  • Horse
  • Cattle
  • Pig
  • Cat
  • Dog
Route of administration:
  • Intraarticular use
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Dexamethasone
    2.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intraarticular use
    • Horse
      • Milk
        no withdrawal period
      • Meat and offal
        8
        day
  • Intravenous use
    • Horse
      • Milk
        no withdrawal period
      • Meat and offal
        8
        day
  • Intramuscular use
    • Cattle
      • Milk
        72
        hour
      • Meat and offal
        8
        day
    • Pig
      • Meat and offal
        2
        day
    • Horse
      • Milk
        no withdrawal period
      • Meat and offal
        8
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Available in:
  • Croatia
Package description:
  • Plastic Vial 1 x 100.0 millilitre(s)

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:
  • Vet-Agro Multi-Trade Company Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Przedsiebiorstwo Wielobranzowe Vet-Agro Sp. z o.o.
  • Przedsiebiorstwo Wielobranzowe Vet-Agro Sp. z o.o.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/22-01/313
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0132/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • France
  • Greece
  • Ireland
  • Poland
  • Portugal
  • Romania
  • Spain

Documents

Summary of Product Characteristics

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Croatian (PDF)
Published on: 24/05/2022
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