FIXR Parvo Lepto
FIXR Parvo Lepto
Authorised
- Leptospira interrogans, serovar Icterohaemorrhagiae, strain MSLB 1041, Inactivated
- Leptospira borgpetersenii, serovar Hardjo, strain MSLB 1039, Inactivated
- Porcine parvovirus, strain Bio-37, Inactivated
- Leptospira interrogans, serovar Canicola, strain MSLB 1043, Inactivated
- Leptospira kirschneri, serovar Grippotyphosa, strain MSLB 1042, Inactivated
- Leptospira interrogans, serovar Bratislava, strain MSLB 1040, Inactivated
- Leptospira interrogans, serovar Pomona, strain MSLB 1037, Inactivated
Product identification
Medicine name:
FIXR Parvo Lepto
Active substance:
- Leptospira interrogans, serovar Icterohaemorrhagiae, strain MSLB 1041, Inactivated
- Leptospira borgpetersenii, serovar Hardjo, strain MSLB 1039, Inactivated
- Porcine parvovirus, strain Bio-37, Inactivated
- Leptospira interrogans, serovar Canicola, strain MSLB 1043, Inactivated
- Leptospira kirschneri, serovar Grippotyphosa, strain MSLB 1042, Inactivated
- Leptospira interrogans, serovar Bratislava, strain MSLB 1040, Inactivated
- Leptospira interrogans, serovar Pomona, strain MSLB 1037, Inactivated
Target species:
-
Pig
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Leptospira interrogans, serovar Icterohaemorrhagiae, strain MSLB 1041, Inactivated0.02/Antibody microagglutination-lytic reaction2.00millilitre(s)
-
Leptospira borgpetersenii, serovar Hardjo, strain MSLB 1039, Inactivated0.03/Antibody microagglutination-lytic reaction2.00millilitre(s)
-
Porcine parvovirus, strain Bio-37, Inactivated
-
Leptospira interrogans, serovar Canicola, strain MSLB 1043, Inactivated0.02/Antibody microagglutination-lytic reaction2.00millilitre(s)
-
Leptospira kirschneri, serovar Grippotyphosa, strain MSLB 1042, Inactivated0.02/Antibody microagglutination-lytic reaction2.00millilitre(s)
-
Leptospira interrogans, serovar Bratislava, strain MSLB 1040, Inactivated0.03/Antibody microagglutination-lytic reaction2.00millilitre(s)
-
Leptospira interrogans, serovar Pomona, strain MSLB 1037, Inactivated0.03/Antibody microagglutination-lytic reaction2.00millilitre(s)
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Pig
-
Meat and offalno withdrawal periodzero days
-
-
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
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
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Published on: 24/01/2022