Veterinary Medicines

Kelevo 800 µg tablets for dogs

Authorised
  • Anhydrous levothyroxine sodium
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Product identification

Medicine name:
Kelevo 800 µg tablets for dogs
Kelevo 800 mcg Tabletka
Active substance:
  • Anhydrous levothyroxine sodium
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Anhydrous levothyroxine sodium
    800.00
    microgram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH03AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • PVC / PE / PVDC - Aluminium blister each with 25 tablets. Cardboard box with 50 tablets
  • PVC / PE / PVDC - Aluminium blister each with 10 tablets. Cardboard box with 100 tablets
  • PVC / PE / PVDC - Aluminium blister each with 10 tablets. Cardboard box with 50 tablets.
  • PVC / PE / PVDC - Aluminium blister each with 10 tablets. Cardboard box with 250 tablets
  • PVC / PE / PVDC - Aluminium blister each with 25 tablets. Cardboard box with 250 tablets
  • PVC / PE / PVDC - Aluminium blister each with 25 tablets. Cardboard box with 100 tablets

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:
  • Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • aniMedica GmbH
  • aniMedica Herstellungs GmbH
  • Industrial Veterinaria S.A.
  • Lelypharma B.V.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3125
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0349/003
Concerned member states:
  • Austria
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Slovenia
  • Spain

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 27/12/2024
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 27/12/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 27/12/2024
Download

Combined File of all Documents

English (PDF)
Published on: 20/03/2024
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