Veterinary Medicines

STENOROL CRYPTO 0.5 mg/ml oral solution for calves

Authorised
  • Halofuginone lactate
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Product identification

Medicine name:
STENOROL CRYPTO 0.5 mg/ml oral solution for calves
Stenorol Crypto 0,5 mg/ml oral opløsning
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:
  • QP51AX08
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • (ID2) 1 litre(s): 1 Bottle (high-density polyethylene) with 1 litre(s), closed with Screw cap (polypropylene)
  • (ID1) 500 millilitre(s): 1 Bottle (high-density polyethylene) with 500 millilitre(s), closed with Screw cap (polypropylene)

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:
  • HuVepharma
Marketing authorisation date:
Manufacturing sites for batch release:
  • Biovet AD
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 62698
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0329/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Danish (PDF)
Published on: 29/06/2023
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Combined File of all Documents

English (PDF)
Published on: 30/01/2026
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2402681-paren-20210112.pdf

English (PDF)
Published on: 30/01/2026
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