Gabbrostim 2 mg/ml Oplossing voor injectie
Gabbrostim 2 mg/ml Oplossing voor injectie
Authorised
- Alfaprostol
Product identification
Medicine name:
Gabbrostim 2 mg/ml Oplossing voor injectie
Gabbrostim 2 mg/ml Solution injectable
Gabbrostim 2 mg/ml Injektionslösung
Active substance:
- Alfaprostol
Target species:
-
Horse
-
Pig
-
Cattle
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Alfaprostol2.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Horse
-
Meat and offal24hourAnimals aimed for human consumption can only be slaughtered 24h after last treatment.
-
Milk24hourMilk from treated animals can only be used for human consumption 24h after treatment.
-
-
Pig
-
Meat and offal24hourAnimals aimed for human consumption can only be slaughtered 24h after last treatment.
-
-
Cattle
-
Meat and offal24hourAnimals aimed for human consumption can only be slaughtered 24h after last treatment.
-
Milk24hourMilk from treated animals can only be used for human consumption 24h after treatment.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QG02AD94
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Gabbrostim 12 Vials with 50 ml of Solution for injection
- Gabbrostim 12 Vials with 20 ml of Solution for injection
- Gabbrostim 12 Vials with 4 ml of Solution for injection
- Gabbrostim 1 Vial with 50 ml of Solution for injection
- Gabbrostim 1 Vial with 20 ml of Solution for injection
- Gabbrostim 1 Vial with 4 ml of Solution for injection
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:
- Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
- Vetem S.p.A.
- Ceva Sante Animale
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V166101
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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Labelling
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