Kelevo 200 µg tablets for dogs and cats
Kelevo 200 µg tablets for dogs and cats
Authorised
- Anhydrous levothyroxine sodium
Product identification
Medicine name:
Kelevo 200 µg tablets for dogs and cats
KELEVO 200 μg COMPRIMIDOS PARA PERROS Y GATOS
Active substance:
- Anhydrous levothyroxine sodium
Target species:
-
Dog
-
Cat
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Anhydrous levothyroxine sodium200.00microgram(s)1.00Piece
Pharmaceutical form:
-
Tablet
Withdrawal period by route of administration:
-
Oral use
- Dog
- Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QH03AA01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Spain
Available in:
-
Spain
Package description:
- PVC / PE / PVDC - Aluminium blister each with 25 tablets. Cardboard box with 50 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.
- 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 10 tablets. Cardboard box with 100 tablets.
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:
- Livisto Int'l S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
- Animedica GmbH
- Animedica Herstellungs GmbH
- Industrial Veterinaria S.A.
- Lelypharma B.V.
Responsible authority:
- Spanish Agency For Medicines And Health Products
Authorisation number:
- 3993 ESP
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0349/001
Concerned member states:
-
Austria
-
Estonia
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Poland
-
Portugal
-
Slovenia
-
Spain
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 8/04/2024
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 8/04/2024
Labelling
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 8/04/2024
Combined File of all Documents
English (PDF)
Download Published on: 20/03/2024
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