NICILAN 200 mg/50 mg tablets for dogs
NICILAN 200 mg/50 mg tablets for dogs
Authorised
- Amoxicillin trihydrate
- Potassium clavulanate
Product identification
Medicine name:
NICILAN 200 mg/50 mg tablets for dogs
Nicilan 200 mg + 50 mg Tabletka
Active substance:
- Amoxicillin trihydrate
- Potassium clavulanate
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Amoxicillin trihydrate200.00/milligram(s)1.00Tablet
-
Potassium clavulanate50.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Tablet
Withdrawal period by route of administration:
-
Oral use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01CR02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Poland
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:
- Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
- 2033
Reference member state:
-
Spain
Procedure number:
- ES/V/0155/002
Concerned member states:
-
Germany
-
Greece
-
Italy
-
Poland
-
Portugal
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 5/04/2023
Polish (PDF)
Published on: 4/02/2022
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