Veterinary Medicines Information website

NICILAN 200 mg/50 mg tablets for dogs

Authorised
  • Potassium clavulanate
  • Amoxicillin trihydrate
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Product identification

Medicine name:
NICILAN 200 mg/50 mg tablets for dogs
Active substance:
  • Potassium clavulanate
  • Amoxicillin trihydrate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Potassium clavulanate
    59.53
    milligram(s)
    /
    1.00
    Tablet
  • Amoxicillin trihydrate
    229.55
    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:
  • Greece
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:
  • National Organization For Medicines
Authorisation number:
  • 71602/04-07-2023/K-0221702
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0155/002
Concerned member states:
  • Germany
  • Greece
  • Italy
  • Poland
  • Portugal