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NOROCLAV 250 mg, comprimate

Authorised
  • Potassium clavulanate
  • Amoxicillin
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Product identification

Medicine name:
NOROCLAV 250 mg, comprimate
Active substance:
  • Potassium clavulanate
  • Amoxicillin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Potassium clavulanate
    52.50
    milligram(s)
    /
    1.00
    Tablet
  • Amoxicillin
    200.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CR02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Available 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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 190100
Date of authorisation status change:

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 23/08/2024
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