Suvaxyn Parvo–E Amphigen
Suvaxyn Parvo–E Amphigen
Not authorised
- Porcine parvovirus, strain S-80, Inactivated
- Erysipelothrix rhusiopathiae, serotype 2, Inactivated
Product identification
Medicine name:
Suvaxyn Parvo–E Amphigen
Suvaxyn Parvo/Ery Inaktywowany parwowirus świń, szczep S-80 HI ≥ 94,1*;Inaktywowane bakterie Erysipelothrix rhusiopathiae, serotyp 2, szczep B-7 RP 1-13,5**.(*)Średnia geometryczna miana przeciwciał hamujących hemaglutynację po szczepieniu królików jednądawką stanowiącą połowę rozcieńczenia szczepionki badanej **Moc względna w porównaniu dosurowicy referencyjnej otrzymanej po immunizacji świń szczepionką, która zapewnia wystarczającąochronę,(***) 60% (13,8 mg ) stanowi parafina ciekła Emulsja do wstrzykiwań
Active substance:
- Porcine parvovirus, strain S-80, Inactivated
- Erysipelothrix rhusiopathiae, serotype 2, Inactivated
Target species:
-
Pig
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Porcine parvovirus, strain S-80, Inactivated94.10/haemagglutination inhibiting unit(s)2.00millilitre(s)
-
Erysipelothrix rhusiopathiae, serotype 2, Inactivated13.50/relative potency2.00millilitre(s)
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Pig
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI09AL01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Surrendered
Authorised in:
-
Poland
Package description:
- box containing 1 vial of 50 ml (25 doses)
- box containing 1 vial of 20 ml (10 doses)
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Zoetis Polska Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
- Zoetis Manufacturing & Research Spain S.L.
- VMD
- PEI
Responsible authority:
- Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
- 2682
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0266/001
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Labelling
This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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