Veterinary Medicines

ALFADEXX 2 MG/ML SOLUTION FOR INJECTION FOR HORSES, CATTLE, GOATS, PIGS, DOGS AND CATS

Authorised
  • DEXAMETHASONE DISODIUM PHOSPHATE
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Product identification

Medicine name:
ALFADEXX 2 MG/ML SOLUTION FOR INJECTION FOR HORSES, CATTLE, GOATS, PIGS, DOGS AND CATS
Alfadexx 2 mg/ml roztwór do wstrzykiwań dla koni, bydła, kóz, świń, psów i kotów
Active substance:
  • DEXAMETHASONE DISODIUM PHOSPHATE
Target species:
  • Cattle
  • Pig
  • Cat
  • Horse
  • Goat
  • Dog
Route of administration:
  • Intramuscular use
  • Subcutaneous use
  • Periarticular use
  • Intravenous use
  • Intraarticular use

Product details

Active substance and strength:
  • DEXAMETHASONE DISODIUM PHOSPHATE
    2.63
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        8
        day
      • Milk
        72
        hour
    • Pig
      • Meat and offal
        2
        day
    • Cat
    • Horse
      • Meat and offal
        8
        day
      • Milk
        no withdrawal period
    • Goat
      • Meat and offal
        8
        day
      • Milk
        72
        hour
    • Dog
  • Subcutaneous use
    • Dog
    • Cat
  • Periarticular use
    • Horse
      • Meat and offal
        8
        day
      • Milk
        no withdrawal period
  • Intravenous use
    • Cattle
      • Meat and offal
        8
        day
      • Milk
        72
        hour
    • Pig
      • Meat and offal
        6
        day
    • Cat
    • Horse
      • Meat and offal
        8
        day
      • Milk
        no withdrawal period
    • Goat
      • Meat and offal
        8
        day
      • Milk
        72
        hour
    • Dog
  • Intraarticular use
    • Horse
      • Meat and offal
        8
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:

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:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
  • Alfasan Nederland B.V.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3173
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0430/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/05/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/05/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/05/2022
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