Veterinary Medicines

RP Vacc vakcina A.U.V.

Authorised
  • Pigeon rotavirus, strain Ro/D, Inactivated
  • Pigeon paramyxovirus 1, strain 988M, Inactivated
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Product identification

Medicine name:
RP Vacc vakcina A.U.V.
RP Vacc emulsie voor injectie voor duiven
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, Inactivated
    52.20
    enzyme-linked immunosorbent assay unit
    /
    0.30
    millilitre(s)
  • Pigeon paramyxovirus 1, strain 988M, Inactivated
    6.47
    log2 haemagglutination inhibiting unit(s)
    /
    0.30
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pigeon
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01EA
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 128059
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

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 19/01/2022
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