FIXR MS-VAC Emulsion for injection for chickens
FIXR MS-VAC Emulsion for injection for chickens
Authorised
- Mycoplasma synoviae, strains MS-NEV1 and MS-NEV2, Inactivated
Product identification
Medicine name:
FIXR MS-VAC Emulsion for injection for chickens
Active substance:
- Mycoplasma synoviae, strains MS-NEV1 and MS-NEV2, Inactivated
Target species:
-
Chicken
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Mycoplasma synoviae, strains MS-NEV1 and MS-NEV2, Inactivated10.00/log10 colony forming unit(s)0.50millilitre(s)
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Subcutaneous use
-
Chicken
-
Meat and offal0day
-
Egg0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI01AB03
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Polypropylene bottles of 310 ml (extractable contents are 250 ml) with a closure of elastomer stoppers and aluminium caps
- Box containing 10 Polypropylene bottles of 310 ml (extractable contents are 250 ml) with a closure of elastomer stoppers and aluminium caps
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:
- Fatro S.p.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V560613
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0302/001
Concerned member states:
-
Belgium
-
Czechia
-
Germany
-
Hungary
-
Portugal
-
Romania
-
Spain
-
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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