Libromide 325 mg tablets for dogs
Libromide 325 mg tablets for dogs
Authorised
- Potassium bromide
Product identification
Medicine name:
Libromide 325 mg tablets for dogs
Libromide 325 mg tabletter til hund
Active substance:
- Potassium bromide
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Potassium bromide325.00/milligram(s)1.00Tablet
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:
-
Norway
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:
- Norwegian Medical Products Agency
Authorisation number:
- 11-8462
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 28/01/2022
Norwegian (PDF)
Published on: 13/11/2023
How useful was this page?:
