Tsefalen 50mg/ml Powder for Oral Suspension for Dogs up to 20kg and Cats
Tsefalen 50mg/ml Powder for Oral Suspension for Dogs up to 20kg and Cats
Authorised
- Cefalexin
Product identification
Medicine name:
Tsefalen 50mg/ml Powder for Oral Suspension for Dogs up to 20kg and Cats
Tsefalen 50 mg/ml Poeder voor orale suspensie
Tsefalen 50 mg/ml Poudre pour suspension buvable
Tsefalen 50 mg/ml Pulver zur Herstellung einer Suspension zum Einnehmen
Active substance:
- Cefalexin
Target species:
-
Cat
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Cefalexin50.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Powder for oral suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01DB01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Carton box with 1 bottle containing 40.0 g of powder providing 60 ml of suspension after reconstitution and 1 syringe of 5 ml
- Carton box with 1 bottle containing 66.6 g of powder providing 100 ml of suspension after reconstitution and 1 syringe of 5 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Nextmune Italy S.r.l.
Marketing authorisation date:
Manufacturing sites for batch release:
- Acs Dobfar S.p.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V572160
Date of authorisation status change:
Reference member state:
-
Italy
Procedure number:
- IT/V/0142/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Latvia
-
Liechtenstein
-
Lithuania
-
Luxembourg
-
Malta
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 8/03/2024
Italian (PDF)
Published on: 3/03/2022
Summary of Product Characteristics
This document does not exist in this language (English). You can find it
in another language below.
Package Leaflet
This document does not exist in this language (English). You can find it
in another language below.
Labelling
This document does not exist in this language (English). You can find it
in another language below.
