Veterinary Medicines

NICILAN 40 mg/10 mg tablets for dogs and cats

Authorised
  • Potassium clavulanate
  • Amoxicillin trihydrate
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Product identification

Medicine name:
NICILAN 40 mg/10 mg tablets for dogs and cats
Nicilan 40 mg/10 mg comprimidos para cães e gatos.
Active substance:
  • Potassium clavulanate
  • Amoxicillin trihydrate
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Potassium clavulanate
    10.00
    milligram(s)
    /
    1.00
    Tablet
  • Amoxicillin trihydrate
    40.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:
  • box containing 12 tablets (1 blister)
  • box containing 60 tablets (5 blister)
  • box containing 120 tablets (10 blister)
  • box containing 240 tablets (20 blister)

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:
  • Calier Portugal Medicamentos E Produtos Veterinarios S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 265/01/10RFVPT
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0155/001
Concerned member states:
  • Germany
  • Greece
  • Italy
  • Poland
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 8/05/2025
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Package Leaflet

English (PDF)
Published on: 8/05/2025
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Labelling

English (PDF)
Published on: 5/04/2023
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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: 24/06/2025
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