Gentaject 10% Solution for Injection for Horses
Gentaject 10% Solution for Injection for Horses
Authorised
- Gentamicin sulfate
Product identification
Medicine name:
Gentaject 10% Solution for Injection for Horses
Active substance:
- Gentamicin sulfate
Target species:
-
Horse
-
Horse (non food-producing)
Route of administration:
-
Intramuscular use
-
Intravenous use
Product details
Active substance and strength:
-
Gentamicin sulfate170.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Horse
-
Meat and offal6month
-
-
-
Intravenous use
-
Horse
-
Meat and offal6month
-
-
Horse (non food-producing)
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01GB03
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Ireland
Package description:
- 100 ml clear, Type II glass vial sealed with bromobutyl bung and aluminium overseal.
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:
- Franklin Pharmaceuticals Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- DIVASA-FARMAVIC, S.A.
Responsible authority:
- Health Products Regulatory Authority
Authorisation number:
- VPA10976/002/001
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
English (PDF)
Download Published on: 3/05/2024
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