Veterinary Medicines

NICILAN 400 mg/100 mg tablets for dogs

Authorised
  • Amoxicillin trihydrate
  • Potassium clavulanate
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Product identification

Medicine name:
NICILAN 400 mg/100 mg tablets for dogs
Nicilan 400 mg/100 mg
Active substance:
  • Amoxicillin trihydrate
  • Potassium clavulanate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    400.00
    milligram(s)
    /
    1.00
    Tablet
  • Potassium clavulanate
    100.00
    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:
  • Germany
Package description:
  • box containing 240 tablets (40 blister)
  • box containing 120 tablets (20 blister)
  • box containing 60 tablets (10 blister)
  • box containing 12 tablets (2 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:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401408.00.00
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0155/003
Concerned member states:
  • Germany
  • Greece
  • Italy
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 5/04/2023
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German (PDF)
Published on: 20/12/2024
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Package Leaflet

English (PDF)
Published on: 5/04/2023
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Labelling

English (PDF)
Published on: 5/04/2023
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