NIGLUMINE
NIGLUMINE
Authorised
- Flunixin meglumine
Product identification
Medicine name:
NIGLUMINE
НИГЛУМИН 50 мг/мл инжекционен разтвор за говеда, коне и прасета
Active substance:
- Flunixin meglumine
Target species:
-
Cattle
-
Horse
-
Pig
Route of administration:
-
Intramuscular use
-
Intravenous use
Product details
Active substance and strength:
-
Flunixin meglumine5.00/gram(s)100.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
Meat and offal4day
-
Milk24hour
-
- Horse
-
Meat and offal28day
-
- Pig
-
Meat and offal28day
-
-
Intravenous use
- Cattle
-
Meat and offal4day
-
Milk24hour
-
- Horse
-
Meat and offal28day
-
- Pig
-
Meat and offal28day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AG90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Bulgaria
Available in:
-
Bulgaria
Package description:
- box containing 1 vial of 50 ml
- box containing 1 vial of 250 ml
- box containing 1 vial of 100 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:
- Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Laboratorios Calier S.A.
Responsible authority:
- Bulgarian Agency For Food Safety
Authorisation number:
- 0022-1717-24.02.2012
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0127/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Germany
-
Greece
-
Hungary
-
Italy
-
Netherlands
-
Portugal
-
Romania
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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