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
Withdrawal period by route of administration:
  • Oral use
    • Dog
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.
  • Surepharm Services Limited
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

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 5/04/2024
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Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
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