Genta-Equine 100 mg/ml Solution for injection
Genta-Equine 100 mg/ml Solution for injection
Authorised
- Gentamicin sulfate
Product identification
Medicine name:
Genta-Equine 100 mg/ml Oplossing voor injectie
Genta-Equine 100 mg/ml Solution injectable
Genta-Equine 100 mg/ml Injektionslösung
Genta-Equine 100 mg/ml Solution for injection
Active substance:
- Gentamicin sulfate
Target species:
-
Horse
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Gentamicin sulfate169.40/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
-
Horse
-
Meat and offalno withdrawal periodNot authorised for use in horses producing meat for human consumption.
-
Milkno withdrawal periodNot authorised for use in horses producing milk for human consumption.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01GB03
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Genta-Equine 100 mg/ml inj. sol. i.v. vial 100 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Franklin Pharmaceuticals Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Divasa Farmavic S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V477520
Date of authorisation status change:
Reference member state:
-
Belgium
Procedure number:
- BE/V/0045/001
Concerned member states:
-
Denmark
-
Iceland
-
Spain
-
United Kingdom (Northern Ireland)
Generic of:
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: 3/01/2022
Package Leaflet
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Summary of Product Characteristics
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Labelling
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