Veterinary Medicines

Libromide 325 mg tablets for dogs

Authorised
  • Potassium bromide
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Product identification

Medicine name:
Libromide 325 mg tablets for dogs
Libromide 325 mg compresse per cani
Active substance:
  • Potassium bromide
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Potassium bromide
    325.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM11
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • Pack size 100: White, opaque polypropylene cylindrical pots, with white, opaque polyethylene child resistant or tamper evident lids.
  • Pack size 500: White, opaque polypropylene cylindrical pots, with white, opaque polyethylene child resistant or tamper evident lids.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 104422
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0507/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 1/08/2024
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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