Labiprofen 150 mg/ml solution for injection
Labiprofen 150 mg/ml solution for injection
Authorised
- Ketoprofen
Product identification
Medicine name:
Labiprofen 150 mg/ml solution for injection
Labiprofen 150 mg/ml raztopina za injiciranje za govedo, prašiče in konje
Active substance:
- Ketoprofen
Target species:
-
Cattle
-
Pig
-
Horse
Route of administration:
-
Intramuscular use
-
Intravenous use
Product details
Active substance and strength:
-
Ketoprofen150.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
- Pig
- Horse
-
Intravenous use
- Cattle
- Pig
- Horse
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AE03
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Slovenia
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:
- Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Labiana Life Sciences S.A.
Responsible authority:
- Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
- DC/V/0731/001
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0388/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Norway
-
Portugal
-
Romania
-
Slovenia
-
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: 12/04/2023
Slovenian (PDF)
Published on: 28/04/2023
Package Leaflet and Labelling
This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 28/04/2023
Package Leaflet
English (PDF)
Download Published on: 24/03/2023
Labelling
English (PDF)
Download Published on: 24/03/2023
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