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 peroralna raztopina za teleta
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:
  • Slovenia
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:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0711/001
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

English (PDF)
Published on: 11/02/2022
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Slovenian (PDF)
Published on: 28/10/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 28/10/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 28/10/2024
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Combined File of all Documents

English (PDF)
Published on: 6/08/2024
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