Veterinary Medicines

Clindabactin 440 mg Chewable Tablets for Dogs

Authorised
  • Clindamycin hydrochloride
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Product identification

Medicine name:
Clindabactin 440 mg Chewable Tablets for Dogs
Clindabactin 440 mg Tuggtablett
Active substance:
  • Clindamycin hydrochloride
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Clindamycin hydrochloride
    440.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FF01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Sweden
Package description:
  • Aluminium - Polyamide/Aluminium/PVC blister. Cardboard box containing 10 separate cardboard boxes, each containing 1 blister of 10 tablets.
  • Aluminium - Polyamide/Aluminium/PVC blister.Cardboard box of 8 blisters of 10 tablets.
  • Aluminium - Polyamide/Aluminium/PVC blister.Cardboard box of 6 blisters of 10 tablets.
  • Aluminium - Polyamide/Aluminium/PVC blister.Cardboard box of 4 blisters of 10 tablets.
  • Aluminium - Polyamide/Aluminium/PVC blister.Cardboard box of 3 blisters of 10 tablets.
  • Aluminium - Polyamide/Aluminium/PVC blister.Cardboard box of 25 blisters of 10 tablets.
  • Aluminium - Polyamide/Aluminium/PVC blister.Cardboard box of 1 blister of 10 tablets.
  • Aluminium - Polyamide/Aluminium/PVC blister.Cardboard box of 9 blisters of 10 tablets.
  • Aluminium - Polyamide/Aluminium/PVC blister.Cardboard box of 7 blisters of 10 tablets.
  • Aluminium - Polyamide/Aluminium/PVC blister.Cardboard box of 5 blisters of 10 tablets.
  • Aluminium - Polyamide/Aluminium/PVC blister.Cardboard box of 2 blisters of 10 tablets.
  • Aluminium - Polyamide/Aluminium/PVC blister.Cardboard box of 10 blisters of 10 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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
  • Genera d.d.
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 57488
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0317/003
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 17/04/2025
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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.
Swedish (PDF)
Published on: 17/04/2025
Download

Combined File of all Documents

English (PDF)
Published on: 24/03/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 17/04/2025
Download

Clindabactin 55 220 en 440 mg - Puar.pdf

English (PDF)
Published on: 23/12/2024
Download
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