Veterinary Medicines

Selehold 120 mg spot-on solution for dogs 10.1–20.0 kg

Authorised
  • Selamectin
Download as PDF

Product identification

Medicine name:
Selehold 120 mg spot-on solution for dogs 10.1–20.0 kg
Selehold 120 mg разтвор за прилагане върху ограничен участък за кучета 10,1–20 kg
Active substance:
  • Selamectin
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Selamectin
    120.00
    milligram(s)
    /
    1.00
    Pipette
Pharmaceutical form:
  • Spot-on solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
Package description:
  • Translucent polypropylene unit-dose pipette with polyethylene or polyoxymethylene or polypropylene closure with spikepackaged into a laminated triplex bag composed of polyester, aluminium and polyethylene. 3 ml pipette containing 1.0 ml of solution.Cardboard box containing 1 pipette.
  • Translucent polypropylene unit-dose pipette with polyethylene or polyoxymethylene or polypropylene closure with spikepackaged into a laminated triplex bag composed of polyester, aluminium and polyethylene. 3 ml pipette containing 1.0 ml of solution.Cardboard box containing 3 pipettes.
  • Translucent polypropylene unit-dose pipette with polyethylene or polyoxymethylene or polypropylene closure with spikepackaged into a laminated triplex bag composed of polyester, aluminium and polyethylene. 3 ml pipette containing 1.0 ml of solution.Cardboard box containing 6 pipettes.
  • Translucent polypropylene unit-dose pipette with polyethylene or polyoxymethylene or polypropylene closure with spikepackaged into a laminated triplex bag composed of polyester, aluminium and polyethylene. 3 ml pipette containing 1.0 ml of solution.Cardboard box containing 15 pipettes.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • TAD Pharma GmbH
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2850
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0395/003
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
Bulgarian (PDF)
Published on: 12/01/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 12/01/2024
Download