Veterinary Medicines

Toxovax

Authorised
  • Toxoplasma gondii, strain S48, Live
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Product identification

Medicine name:
Toxovax
Active substance:
  • Toxoplasma gondii, strain S48, Live
Target species:
  • Sheep
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Toxoplasma gondii, strain S48, Live
    7500000.00
    other
    /
    1.00
    Dose
Pharmaceutical form:
  • Concentrate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Sheep
      • Meat and offal
        42
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI04AN01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Carton box with 1 vial of 20 doses of vaccine and a vial of 40 ml of diluent, and a transfer spike.Vaccine:Type I Ph.Eur. glass vials, closed with a halogenobutyl rubber stopper and sealed with a colour coded aluminium cap,containing 2 ml (20 doses) of vaccine concentrate.Diluent:Hydrolytic Type II Ph.Eur. glass vials with halogenated butyl rubber stopper and an aluminium crimp cap containing 40 ml (for 20 doses) diluent
  • Carton box with 1 vial of 20 doses of vaccine and a vial of 40 ml of diluent, and a transfer spike.Vaccine:Type I Ph.Eur. glass vials, closed with a halogenobutyl rubber stopper and sealed with a colour coded aluminium cap,containing 2 ml (20 doses) of vaccine concentrate.Diluent:PET (polyethylene terephthalate) vials with halogenated butyl rubber stopper and an aluminium crimp cap containing 40 ml (for 20 doses) diluent
  • Carton box with 1 vial of 50 doses of vaccine and a carton box with 100ml of diluent (add transfer spike if appropriate to either carton). Vaccine:Type I Ph.Eur. glass vials, closed with a halogenobutyl rubber stopper and sealed with a colour coded aluminium cap, containing 5 ml (50 doses) of vaccine concentrate.Diluent:Hydrolytic Type II Ph. Eur. glass vials with halogenated butyl rubber stopper and an aluminium crimp cap containing 100 ml (for 50 doses) diluent.
  • Carton box with 1 vial of 50 doses of vaccine and a carton box with 100ml of diluent (add transfer spike if appropriate to either carton). Vaccine:Type I Ph.Eur. glass vials, closed with a halogenobutyl rubber stopper and sealed with a colour coded aluminium cap, containing 5 ml (50 doses) of vaccine concentrate.Diluent:PET (polyethylene terephthalate) vials with halogenated butyl rubber stopper and an aluminium crimp cap containing 100 ml (for 50 doses) diluent.
  • Carton box with 1 vial of 50 doses of vaccine and a vial of 100ml of diluent, and a transfer spike.Vaccine:Type I Ph.Eur. glass vials, closed with a halogenobutyl rubber stopper and sealed with a colour coded aluminium cap,containing 5 ml (50 doses) of vaccine concentrate.Diluent:PET (polyethylene terephthalate) vials with halogenated butyl rubber stopper and an aluminium crimp cap containing 100 ml (for 50 doses) diluent.
  • Carton box with 1 vial of 20 doses of vaccine and a carton box with 40ml of diluent (add transfer spike if appropriate to either carton). Vaccine:Type I Ph.Eur. glass vials, closed with a halogenobutyl rubber stopper and sealed with a colour coded aluminium cap, containing 2 ml (20 doses) of vaccine concentrate.Diluent:Hydrolytic Type II Ph.Eur. glass vials with halogenated butyl rubber stopper and an aluminium crimp cap containing 20 ml (for 20 doses) diluent.
  • Carton box with 1 vial of 20 doses of vaccine and a carton box with 40ml of diluent (add transfer spike if appropriate to either carton). Vaccine:Type I Ph.Eur. glass vials, closed with a halogenobutyl rubber stopper and sealed with a colour coded aluminium cap,containing 2 ml (20 doses) of vaccine concentrate.Diluent:PET (polyethylene terephthalate) vials with halogenated butyl rubber stopper and an aluminium crimp cap containing 20 ml (for 20 doses) diluent.
  • Carton box with 1 vial of 50 doses of vaccine and a vial of 100ml of diluent, and a transfer spike.Vaccine:Type I Ph.Eur. glass vials, closed with a halogenobutyl rubber stopper and sealed with a colour coded aluminium cap,containing 5 ml (50 doses) of vaccine concentrate.Diluent:Hydrolytic Type II Ph.Eur. glass vials with halogenated butyl rubber stopper and an aluminium crimp cap containing 100 ml (for 50 doses) diluent.

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:
  • Intervet (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10996/080/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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