Veterinary Medicines

Selames 30 mg spot-on solution for dogs 2.6–5.0 kg

Authorised
  • Selamectin
Download as PDF

Product identification

Medicine name:
Selames 30 mg spot-on solution for dogs 2.6–5.0 kg
Selames 30 mg solução para unção punctiforme para cães com 2,6–5,0 kg
Active substance:
  • Selamectin
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Selamectin
    30.00
    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:
  • Portugal
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:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1217/01/18DFVPT
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0407/001
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
Download

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 17/08/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."