HYOGEN EMULSION FOR INJECTION
HYOGEN EMULSION FOR INJECTION
Authorised
- Mycoplasma hyopneumoniae, strain 2940, Inactivated
Product identification
Medicine name:
HYOGEN EMULSION FOR INJECTION
Hyogen J5 Emulsie voor injectie
Hyogen J5 Emulsion injectable
Hyogen J5 Emulsion zur Injektion
Active substance:
- Mycoplasma hyopneumoniae, strain 2940, Inactivated
Target species:
-
Pigs (for fattening)
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Mycoplasma hyopneumoniae, strain 2940, Inactivated328.00enzyme-linked immunosorbent assay unit2.00millilitre(s)
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Pigs (for fattening)
-
All relevant tissues0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI09AB13
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Cardboard box of 5 bottles of 50 ml (5x25 doses)
- Cardboard box of 1 bottle of 100 ml (1x50 doses)
- Cardboard box of 5 bottles of 100 ml (5x50 doses)
- Cardboard box of 1 bottle of 200 ml (1x100 doses)
- Cardboard box of 5 bottles of 200 ml (5x100 doses)
- Cardboard box of 200 ml in 1 bottle of 250 ml (1x100 doses)
- Cardboard box of 5x200 ml in 5 bottles of 250 ml (5x100 doses)
- Cardboard box of 1 bottle of 250 ml (1x125 doses)
- Cardboard box of 5 bottles of 250 ml (1x125 doses)
- Cardboard box of 1 bottle of 50 ml (1x25 doses)
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
- Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V474524
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0278/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
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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Package Leaflet
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Labelling
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