Veterinary Medicines

HEMOSILATE 125 mg/ml solution for injection

Authorised
  • Etamsylate
Download as PDF

Product identification

Medicine name:
Hemosilate 125 mg/ml Oplossing voor injectie
Hemosilate 125 mg/ml Solution injectable
Hemosilate 125 mg/ml Injektionslösung
HEMOSILATE 125 mg/ml solution for injection
Active substance:
  • Etamsylate
Target species:
  • Cattle
  • Sheep
  • Goat
  • Pig
  • Horse
  • Dog
  • Cat
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Etamsylate
    125.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        0
        day
    • Sheep
      • Meat and offal
        no withdrawal period
      • Milk
        0
        day
    • Goat
      • Meat and offal
        no withdrawal period
      • Milk
        0
        day
    • Pig
      • Meat and offal
        no withdrawal period
    • Horse
      • Meat and offal
        no withdrawal period
      • Milk
        0
        day
    • Dog
    • Cat
  • Intramuscular use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        0
        day
    • Sheep
      • Meat and offal
        no withdrawal period
      • Milk
        0
        day
    • Goat
      • Meat and offal
        no withdrawal period
      • Milk
        0
        day
    • Pig
      • Meat and offal
        no withdrawal period
    • Horse
      • Meat and offal
        no withdrawal period
      • Milk
        0
        day
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QB02BX01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • cardboard box containing 1 vial of 20 ml
  • cardboard box containing 5 vials of 20 ml
  • cardboard box containing 10 vials of 20 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:
  • Ecuphar Veterinaria S.L.U.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V557955
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0281/001
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
Download
Dutch (PDF)
Published on: 26/04/2022
Download
French (PDF)
Published on: 26/04/2022
Download

Package Leaflet

English (PDF)
Published on: 22/12/2023
Download
Dutch (PDF)
Published on: 26/04/2022
Download
French (PDF)
Published on: 26/04/2022
Download
German (PDF)
Published on: 26/04/2022
Download

eu-PUAR-esv0281001-dcp-hemosilate-125-mg-ml-solution-for-injection-en.pdf

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