Veterinary Medicines

Mutilan, 125.0mg/ml, Oral solution

Authorised
  • Tiamulin hydrogen fumarate
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Product identification

Medicine name:
Mutilan, 125.0mg/ml, Oral solution
Mutilan, 125.0mg/ml, Perorální roztok
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
    125.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • In drinking water use
    • Pig
      • Meat and offal
        4
        day
    • Chicken
      • Meat and offal
        2
        day
      • Egg
        0
        day
    • Turkey
      • Meat and offal
        5
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01XQ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • Plastic Bottle 1 x 5.0 litre(s)
  • Plastic Bottle 1 x 1.0 litre(s)

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 Karizoo S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Karizoo S.A.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/024/10-C
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0106/001
Concerned member states:
  • Cyprus
  • Greece
  • Hungary
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/05/2022
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Czech (PDF)
Published on: 24/05/2022
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Package Leaflet

English (PDF)
Published on: 24/05/2022
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Czech (PDF)
Published on: 24/05/2022
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Labelling

English (PDF)
Published on: 24/05/2022
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Czech (PDF)
Published on: 24/05/2022
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