Veterinary Medicines

FIXR Parvo Lepto

Authorised
  • Leptospira interrogans, serogroup Pomona, serovar Pomona, strain MSLB 1037, Inactivated
  • Leptospira interrogans, serogroup Australis, serovar Bratislava, strain MSLB 1040, Inactivated
  • Leptospira kirschneri, serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1042, Inactivated
  • Leptospira interrogans, serogroup Canicola, serovar Canicola, strain MSLB 1043, Inactivated
  • Porcine parvovirus, strain CAPM V198 S-27, Inactivated
  • Leptospira borgpetersenii, serogroup Sejroe, serovar Hardjo, strain MSLB 1039, Inactivated
  • Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain MSLB 1041, Inactivated
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Product identification

Medicine name:
FIXR Parvo Lepto
FIXR Parvo Lepto, emulsie voor injectie voor varkens
Active substance:
  • Leptospira interrogans, serogroup Pomona, serovar Pomona, strain MSLB 1037, Inactivated
  • Leptospira interrogans, serogroup Australis, serovar Bratislava, strain MSLB 1040, Inactivated
  • Leptospira kirschneri, serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1042, Inactivated
  • Leptospira interrogans, serogroup Canicola, serovar Canicola, strain MSLB 1043, Inactivated
  • Porcine parvovirus, strain CAPM V198 S-27, Inactivated
  • Leptospira borgpetersenii, serogroup Sejroe, serovar Hardjo, strain MSLB 1039, Inactivated
  • Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain MSLB 1041, Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Leptospira interrogans, serogroup Pomona, serovar Pomona, strain MSLB 1037, Inactivated
    3125.00
    unit(s)
    /
    1.00
    Dose
  • Leptospira interrogans, serogroup Australis, serovar Bratislava, strain MSLB 1040, Inactivated
    25.00
    unit(s)
    /
    1.00
    Dose
  • Leptospira kirschneri, serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1042, Inactivated
    0.02
    unit(s)
    /
    1.00
    Dose
  • Leptospira interrogans, serogroup Canicola, serovar Canicola, strain MSLB 1043, Inactivated
    0.02
    unit(s)
    /
    1.00
    Dose
  • Porcine parvovirus, strain CAPM V198 S-27, Inactivated
    4.00
    unit(s)
    /
    1.00
    Dose
  • Leptospira borgpetersenii, serogroup Sejroe, serovar Hardjo, strain MSLB 1039, Inactivated
    25.00
    unit(s)
    /
    1.00
    Dose
  • Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain MSLB 1041, Inactivated
    0.02
    unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AL
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • carton box 1 × 20 ml glass vials hydrolytic class II
  • PVC box with cap with 10 holes 10 × 10 ml glass vials of hydrolytic class I
  • carton box 1 × 50 ml glass vials hydrolytic class II
  • carton box 1 × 100 ml glass vials hydrolytic class II
  • carton box 1 × 10 ml glass vials hydrolytic class I

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Similar biological application (Article 13(4) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Kernfarm B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 125629
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0335/001
Concerned member states:
  • Belgium

Documents

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Published on: 24/01/2022
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