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 Oplossing voor injectie
Labiprofen 150 mg/ml Solution injectable
Labiprofen 150 mg/ml Injektionslösung
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
-
Meat and offal2day
-
-
Pig
-
Meat and offal3day
-
-
Cattle
-
Milk0hour
-
-
Horse
-
Milkno withdrawal periodMilk: Not authorised for use in mares producing milk for human consumption.
-
-
-
Intravenous use
-
Cattle
-
Meat and offal2day
-
-
Horse
-
Meat and offal1day
-
-
Cattle
-
Milk0hour
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AE03
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- box containing 10 vials of 250 ml
- box containing 10 vials of 100 ml
- box containing 12 vials of 50 ml
- box containing 1 vial of 250 ml
- box containing 1 vial of 100 ml
- box containing 1 vial of 50 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:
- Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Labiana Life Sciences S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V587546
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
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