Veterinary Medicines

HEPAREMIN solution for injection

Not authorised
  • Lysine hydrochloride
  • Methionine
Download as PDF

Product identification

Medicine name:
HEPAREMIN injekčný roztok
HEPAREMIN solution for injection
Active substance:
  • Lysine hydrochloride
  • Methionine
Target species:
  • Horse
  • Cattle
  • Cattle (calf)
  • Pig
  • Sheep
  • Dog
Route of administration:
  • Intravenous use
  • Intraperitoneal use
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Lysine hydrochloride
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Methionine
    25.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
      • All relevant tissues
        0
        day
    • Cattle
      • All relevant tissues
        0
        day
    • Cattle (calf)
      • All relevant tissues
        0
        day
    • Pig
      • All relevant tissues
        0
        day
    • Sheep
      • All relevant tissues
        0
        day
  • Intraperitoneal use
    • Horse
      • All relevant tissues
        0
        day
    • Cattle
      • All relevant tissues
        0
        day
    • Cattle (calf)
      • All relevant tissues
        0
        day
    • Pig
      • All relevant tissues
        0
        day
    • Sheep
      • All relevant tissues
        0
        day
  • Subcutaneous use
    • Horse
      • All relevant tissues
        0
        day
    • Cattle
      • All relevant tissues
        0
        day
    • Cattle (calf)
      • All relevant tissues
        0
        day
    • Pig
      • All relevant tissues
        0
        day
    • Sheep
      • All relevant tissues
        0
        day
  • Intramuscular use
    • Horse
      • All relevant tissues
        0
        day
    • Cattle
      • All relevant tissues
        0
        day
    • Cattle (calf)
      • All relevant tissues
        0
        day
    • Pig
      • All relevant tissues
        0
        day
    • Sheep
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QB05XB03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Slovakia
Package description:
  • Colourless glass bottles glastype I – II, chlorobutyl rubber stopper, aluminium cap. (1x500 ml)
  • Colourless glass bottles glastype I – II, chlorobutyl rubber stopper, aluminium cap. (1x250 ml)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • BB Pharma a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Farmacia Martin a.s.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 99/059/84 – S
Date of authorisation status change:
Reference member state:
  • Slovakia
Procedure number:
  • SK/V/0101/001

Documents

Combined File of all Documents

English (PDF)
Published on: 24/01/2022
Download
Slovak (PDF)
Published on: 18/01/2022
Download