Veterinary Medicines

TILMICOSIN CALIER 250 mg/ml Concentrate for Oral Solution for use in drinking water or milk replacer

Authorised
  • Tilmicosin phosphate
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Product identification

Medicine name:
TILMICOSIN CALIER 250 mg/ml Concentrate for Oral Solution for use in drinking water or milk replacer
TILMICOSIN CALIER 250 mg/ml SOLUCION PARA ADMINISTRACION EN AGUA DE BEBIDA O EN LECHE
Active substance:
  • Tilmicosin phosphate
Target species:
  • Chicken
  • Turkey
  • Pig
  • Cattle (pre-ruminant)
Route of administration:
  • In drinking water/milk use

Product details

Active substance and strength:
  • Tilmicosin phosphate
    278.20
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water/milk
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Chicken
      • Meat and offal
        12
        day
      • Eggs
        no withdrawal period
    • Turkey
      • Meat and offal
        19
        day
    • Pig
      • Meat and offal
        14
        day
    • Cattle (pre-ruminant)
      • Meat and offal
        42
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • bottle of 5 L
  • bottle of 1 L

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:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 3976 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0338/001
Concerned member states:
  • Germany
  • Greece
  • Hungary
  • Italy
  • 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
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Spanish (PDF)
Published on: 17/03/2023
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Labelling

English (PDF)
Published on: 12/04/2023
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Spanish (PDF)
Published on: 17/03/2023
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es-puar-tilmicosin-calier-250-mg-ml-concentrate-for-oral-solution-for-use-in-drinking-water-or-milk-replacer-es.pdf

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