Veterinary Medicines

KETALROM 100

Authorised
  • Ketamine hydrochloride
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Product identification

Medicine name:
KETALROM 100
Active substance:
  • Ketamine hydrochloride
Target species:
  • Dog
  • Cat
  • Horse
  • Cattle
  • Sheep
  • Goat
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Ketamine hydrochloride
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Dog
    • Cat
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Goat
      • Meat and offal, milk
        0
        day
  • Intramuscular use
    • Dog
    • Cat
    • Horse
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Sheep
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Goat
      • Milk
        0
        day
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN01AX03
Legal status of supply:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Complete application (stand-alone) - Directive No 2001/82/EC
Marketing authorisation holder:
  • Romvac Company S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Romvac Company S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 170152
Date of authorisation status change:

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 23/06/2022
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