Veterinary Medicines

Selames 60 mg spot-on solution for dogs 5.1–10.0 kg

Authorised
  • Selamectin
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Product identification

Medicine name:
Selames 60 mg spot-on solution for dogs 5.1–10.0 kg
Selames voor honden 5,1 - 10,0 kg 60 mg Spot-on oplossing
Selames pour chiens 5,1 - 10,0 kg 60 mg Solution pour spot-on
Selames fur Hunde 5,1 - 10,0 kg 60 mg Lösung zum Auftropfen
Active substance:
  • Selamectin
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Selamectin
    60.00
    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:
  • Belgium
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.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.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.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.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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V537075
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0407/002
Concerned member states:
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
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