RP Vacc vakcina A.U.V.
RP Vacc vakcina A.U.V.
Authorised
- Pigeon rotavirus, strain Ro/D, Inactivated
- Pigeon paramyxovirus 1, strain 988M, Inactivated
Product identification
Medicine name:
RP Vacc vakcina A.U.V.
RP Vacc Emulsie voor emulsie voor injectie
RP Vacc Emulsion pour émulsion injectable
RP Vacc Emulsion zur Herstellung einer Emulsion zur Injection
Active substance:
- Pigeon rotavirus, strain Ro/D, Inactivated
- Pigeon paramyxovirus 1, strain 988M, Inactivated
Target species:
-
Pigeon
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Pigeon rotavirus, strain Ro/D, Inactivated52.20enzyme-linked immunosorbent assay unit0.30millilitre(s)
-
Pigeon paramyxovirus 1, strain 988M, Inactivated6.47log2 haemagglutination inhibiting unit(s)0.30millilitre(s)
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Pigeon
-
All relevant tissues0dayZero days
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI01EA
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Cardboard box containing one glass vial, type I closed with chlorobutyl rubber stopper sealed with aluminium cap
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Pharmagal Bio spol. s r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
- Pharmagal Bio spol. s r.o.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V593671
Date of authorisation status change:
Reference member state:
-
Slovakia
Procedure number:
- SK/V/0110/001
Concerned member states:
-
Belgium
-
Czechia
-
Germany
-
Hungary
-
Netherlands
-
Poland
-
Portugal
-
Romania
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Summary of Product Characteristics
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