Authorised

Product identification

Medicine name:
HYMATIL 300 mg/ml Solution for injection for cattle
HYMATIL 300 mg/ml SOLUCION INYECTABLE PARA BOVINO Y OVINO
Active substance:
  • Tilmicosin
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Tilmicosin
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        70
        day
    • Sheep
      • 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
Available in:
  • Spain
Package description:
  • box containing 12 vials of 250 ml
  • box containing 12 vials of 100 ml
  • box containing 12 vials of 50 ml
  • box containing 10 vials of 250 ml
  • box containing 10 vials of 100 ml
  • box containing 10 vials of 50 ml
  • box containing 6 vials of 250 ml
  • box containing 6 vials of 100 ml
  • box containing 6 vials of 50 ml
  • box containing 1 vial of 250 ml
  • box containing 1 vial of 100 ml
  • box containing 1 vial of 50 ml

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
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2059 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0141/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
Download
Spanish (PDF)
Published on: 17/03/2023
Download

Package Leaflet

English (PDF)
Published on: 22/12/2023
Download
Spanish (PDF)
Published on: 17/03/2023
Download

Labelling

English (PDF)
Published on: 22/12/2023
Download
Spanish (PDF)
Published on: 17/03/2023
Download

es-puar-hymatil-300-mg-ml-solution-for-injection-for-cattle-es.pdf

Spanish (PDF)
Published on: 17/03/2023
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000015580