Veterinary Medicines

Selehold 360 mg spot-on solution for dogs 40.1�60.0 kg

Authorised
  • Selamectin
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Product identification

Medicine name:
Selehold 360 mg spot-on solution for dogs 40.1�60.0 kg
Selehold 360 mg kožni nanos, raztopina za pse od 40,1 do 60,0 kg
Active substance:
  • Selamectin
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Selamectin
    360.00
    milligram(s)
    /
    1.00
    Pipette
Pharmaceutical form:
  • Spot-on solution
Withdrawal period by route of administration:
  • Spot-on use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • Translucent polypropylene unit-dose pipette with polyethylene or polyoxymethylene or polypropylene closure with spike packaged into a laminated triplex bag composed of polyester, aluminium and polyethylene. 6 ml pipette containing 3.0 ml of solution. Cardboard box containing 1 pipette.
  • Translucent polypropylene unit-dose pipette with polyethylene or polyoxymethylene or polypropylene closure with spike packaged into a laminated triplex bag composed of polyester, aluminium and polyethylene. 6 ml pipette containing 3.0 ml of solution. Cardboard box containing 3 pipettes.
  • Translucent polypropylene unit-dose pipette with polyethylene or polyoxymethylene or polypropylene closure with spike packaged into a laminated triplex bag composed of polyester, aluminium and polyethylene. 6 ml pipette containing 3.0 ml of solution. Cardboard box containing 6 pipettes.
  • Translucent polypropylene unit-dose pipette with polyethylene or polyoxymethylene or polypropylene closure with spike packaged into a laminated triplex bag composed of polyester, aluminium and polyethylene. 6 ml pipette containing 3.0 ml of solution. Cardboard box containing 15 pipettes.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • Krka d.d. Novo Mesto
  • Tad Pharma GmbH
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0639/006
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0395/005
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • France
  • 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: 11/02/2022
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Slovenian (PDF)
Published on: 29/02/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 29/02/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 29/02/2024
Download
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