Veterinary Medicines

Borrelym 3, Suspension for injection

Authorised
  • Borreliella garinii, strain BR14, Inactivated
  • Borreliella afzelii, strain BR33, Inactivated
  • Borreliella burgdorferi, strain DSM 4681, Inactivated
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Product identification

Medicine name:
Borrelym 3, Suspension for injection
Borrelym 3, injekčná suspenzia pre psy
Active substance:
  • Borreliella garinii, strain BR14, Inactivated
  • Borreliella afzelii, strain BR33, Inactivated
  • Borreliella burgdorferi, strain DSM 4681, Inactivated
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Borreliella garinii, strain BR14, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Borreliella afzelii, strain BR33, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Borreliella burgdorferi, strain DSM 4681, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI07AB04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Package description:
  • Glass Vial 10 x 1.0 millilitre(s)
  • Glass Vial 2 x 1.0 millilitre(s)
  • Glass Vial 20 x 1.0 millilitre(s)
  • Glass Vial 100 x 1.0 millilitre(s)
  • Glass Vial 50 x 1.0 millilitre(s)

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:
  • Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/021/MR/13-S
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0114/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Estonia
  • France
  • Germany
  • Hungary
  • Ireland
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Slovak (PDF)
Published on: 3/10/2024
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