Veterinary Medicines

Karimulina 1000 mg/g granules for use in drinking water for pigs, chickens and turkeys

Authorised
  • Tiamulin hydrogen fumarate
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Product identification

Medicine name:
Karimulina 1000 mg/g granules for use in drinking water for pigs, chickens and turkeys
KARIMULINA 1000 mg/g GRANULADO PARA ADMINISTRACION EN AGUA DE BEBIDA PARA PORCINO POLLOS Y PAVOS
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Pig
  • Chicken
  • Turkey
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Tiamulin hydrogen fumarate
    1000.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Granules for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Pig
      • Meat and offal
        no withdrawal period
    • Chicken
      • Meat and offal
        2
        day
      • Eggs
        0
        day
    • Turkey
      • Meat and offal
        6
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01XQ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • Folding carton of 1 kg
  • Folding carton of 125 g

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:
  • Laboratorios Karizoo S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Karizoo S.A.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 3967 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0336/001
Concerned member states:
  • Cyprus
  • Germany
  • Hungary
  • Italy
  • Poland
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
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Spanish (PDF)
Published on: 17/03/2023
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Package Leaflet

English (PDF)
Published on: 12/04/2023
Download
Spanish (PDF)
Published on: 17/03/2023
Download

Labelling

English (PDF)
Published on: 12/04/2023
Download
Spanish (PDF)
Published on: 17/03/2023
Download

eu-PUAR-karimulina-1000-mg-g-granules-for-use-in-drinking-water-for-pigs--chickens-and-turkeys-en.pdf

English (PDF)
Published on: 12/04/2023
Download

es-puar-karimulina-1000-mg-g-granules-for-use-in-drinking-water-for-pigs--chickens-and-turkeys-es.pdf

Spanish (PDF)
Published on: 17/03/2023
Download
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