Veterinary Medicines

Cryptisel 0.5 mg/ml oral solution for calves

Authorised
  • Halofuginone lactate
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Product identification

Medicine name:
Cryptisel 0.5 mg/ml oral solution for calves
Cryptisel 0,5 mg/ml Lösung zum Eingeben für Kälber
Active substance:
  • Halofuginone lactate
Target species:
  • Cattle (newborn calf)
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Halofuginone lactate
    0.61
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Cattle (newborn calf)
      • Meat and offal
        13
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP51BX01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:
  • box containing 1 bottle of 1000 ml (containing 980 ml of soluci?n)
  • box containing 1 bottle of 500 ml (containing 490 ml of soluci?n)
  • box containing 1 bottle of 300 ml (containing 290 ml of soluci?n)
  • box containing 1 bottle of 1000 ml (containing 980 ml of soluci?n) with a 4 ml metering pump
  • box containing 1 bottle of 500 ml (containing 490 ml of soluci?n) with a 4 ml metering pump
  • box containing 1 bottle of 300 ml (containing 290 ml of soluci?n) with a 4 ml metering pump

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:
  • Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
  • aniMedica GmbH
  • aniMedica Herstellungs GmbH
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 402732.00.00
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0374/001
Concerned member states:
  • Austria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 20/10/2025
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German (PDF)
Published on: 10/01/2025
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Package Leaflet

English (PDF)
Published on: 20/10/2025
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German (PDF)
Published on: 10/01/2025
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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Labelling

English (PDF)
Published on: 20/10/2025
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eu-PUAR-cryptisel-0.5-mg-ml-oral-solution-for-calves-en.pdf

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