Rapidexon 2 mg/ml solution for injection
Rapidexon 2 mg/ml solution for injection
Authorised
- Dexamethasone sodium phosphate
Product identification
Medicine name:
Rapidexon 2 mg/ml solution for injection
Rapidexon 2 mg/ml Oplossing voor injectie
Rapidexon 2 mg/ml Solution injectable
Rapidexon 2 mg/ml Injektionslösung
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 phosphate2.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intraarticular use
-
Horse
-
Meat and offal8day
-
-
-
Intramuscular use
-
Cattle
-
Milk72hour
-
Meat and offal8day
-
-
Pig
-
Meat and offal2day
-
-
Horse
-
Meat and offal8day
-
-
-
Intravenous use
-
Horse
-
Meat and offal8day
-
-
-
Intrabursal use
-
Horse
-
Meat and offal8day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QH02AB02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
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:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Eurovet Animal Health B.V.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V315533
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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in another language below.
Package Leaflet
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Labelling
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Combined File of all Documents
English (PDF)
Download Published on: 1/05/2025
Rapidexon 2 mg.pdf
English (PDF)
Download Published on: 7/06/2022