Veterinary Medicines

COLUMBA

Authorised
  • Pigeon paramyxovirus 1, strain 988M, Inactivated
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Product identification

Medicine name:
COLUMBA
COLUMBA, Injekční emulze
Active substance:
  • Pigeon paramyxovirus 1, strain 988M, Inactivated
Target species:
  • Pigeon
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Pigeon paramyxovirus 1, strain 988M, Inactivated
    5.80
    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:
  • QI01EA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • 9 ml (30 doses) glass vials (type I). The vials are closed with chlorobutyl rubber stopper and sealed with aluminium cap
  • 15 ml (50 doses) glass vials (type I). The vials are closed with chlorobutyl rubber stopper and sealed with aluminium cap
  • 30 ml (100 doses) glass vials (type I). The vials are closed with chlorobutyl rubber stopper and 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:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/042/07-C
Date of authorisation status change:
Reference member state:
  • Slovakia
Procedure number:
  • SK/V/0104/001
Concerned member states:
  • Belgium
  • Czechia
  • Hungary
  • Netherlands
  • Poland

Documents

Combined File of all Documents

English (PDF)
Published on: 26/01/2022
Updated on: 25/08/2023
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