Veterinary Medicines

Rapidexon 2 mg/ml solution for injection

Authorised
  • Dexamethasone sodium phosphate
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Product identification

Medicine name:
Rapidexon 2 mg/ml solution for injection
Rapidexon 2 mg/ml solution for injection
Active substance:
  • Dexamethasone sodium phosphate
Target species:
  • Horse
  • Cattle
  • Pig
  • Dog
  • Cat
Route of administration:
  • Intraarticular use
  • Intramuscular use
  • Intravenous use
  • Intrabursal use

Product details

Active substance and strength:
  • Dexamethasone sodium phosphate
    2.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intraarticular use
    • Horse
      • Meat and offal
        8
        day
  • Intramuscular use
    • Cattle
      • Milk
        72
        hour
      • Meat and offal
        8
        day
    • Pig
      • Meat and offal
        2
        day
    • Horse
      • Meat and offal
        8
        day
    • Dog
    • Cat
  • Intravenous use
    • Horse
      • Meat and offal
        8
        day
  • Intrabursal use
    • Horse
      • 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:
  • Ireland
Package description:
  • 50 ml vial glass type I uncoloured with bromobutyl rubber stopper type I secured with aluminium cap
  • 25 ml vial (filled in 30 ml vial) glass type I uncoloured with bromobutyl rubber stopper type I secured with aluminium cap
  • 100 ml vial glass type I uncoloured with bromobutyl rubber stopper type I secured with aluminium

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:
  • Eurovet Animal Health B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10989/056/001
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0284/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Hungary
  • Ireland
  • Lithuania
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 12/09/2024
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Rapidexon 2 mg.pdf

English (PDF)
Published on: 7/06/2022
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