Veterinary Medicines

CASTOMIX Lyophilisate and suspension for injection for rabbits

Authorised
  • Rabbit haemorrhagic disease virus, strain PHB 98, Inactivated
  • Myxoma virus, strain MAV, Live
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Product identification

Medicine name:
CASTOMIX Lyophilisate and suspension for injection for rabbits
Castomix Liofilizat i zawiesina do wstrzykiwań
Active substance:
  • Rabbit haemorrhagic disease virus, strain PHB 98, Inactivated
  • Myxoma virus, strain MAV, Live
Target species:
  • Rabbit
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Rabbit haemorrhagic disease virus, strain PHB 98, Inactivated
    1280.00
    haemagglutinating units
    /
    0.50
    millilitre(s)
  • Myxoma virus, strain MAV, Live
    3.00
    log10 50% tissue culture infectious dose
    /
    0.50
    millilitre(s)
Pharmaceutical form:
  • Lyophilisate and suspension for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Rabbit
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI08AH01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • Type I glass vial lyophilisate and suspension). Chlorobutyl rubber stopper (vials of 40 doses of suspension). Bromobutyl rubber stopper (vials of 40 doses of lyophilisate). Aluminium cap
  • Type I glass vial lyophilisate and suspension). Chlorobutyl rubber stopper (vials of 20 doses of suspension). Bromobutyl rubber stopper (vials of 20 doses of lyophilisate). Aluminium cap
  • Type I glass vial lyophilisate and suspension). Chlorobutyl rubber stopper (vials of 10 doses of suspension). Bromobutyl rubber stopper (vials of 10 doses of lyophilisate). Aluminium cap
  • Type I glass vial lyophilisate and suspension). Chlorobutyl rubber stopper (vials of 5 doses of suspension). Bromobutyl rubber stopper (vials of 5 doses of lyophilisate). Aluminium cap
  • Type I glass vial lyophilisate and suspension). Chlorobutyl rubber stopper (vials of 1 dose of suspension). Bromobutyl rubber stopper (vials of 1 dose of lyophilisate). Aluminium cap

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Pharmagal Bio spol. s r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pharmagal Bio spol. s r.o.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1744
Date of authorisation status change:
Reference member state:
  • Slovakia
Procedure number:
  • SK/V/0103/001
Concerned member states:
  • Poland
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