Rominervin 10 mg/ml Solution for Injection for Horses
Rominervin 10 mg/ml Solution for Injection for Horses
Authorised
- Romifidine hydrochloride
Product identification
Medicine name:
Rominervin 10 mg/ml Solution for Injection for Horses
Rominervin 10 mg/ml Oplossing voor injectie
Rominervin 10 mg/ml Solution injectable
Rominervin 10 mg/ml Injektionslösung
Active substance:
- Romifidine hydrochloride
Target species:
-
Horse
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Romifidine hydrochloride10.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
- Horse
-
Meat and offal6day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05CM93
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Multi-pack with 6 boxes each containing 1 vial of 50 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
- Multi-pack with 6 boxes each containing 1 vial of 20 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
- Multi-pack with 6 boxes each containing 1 vial of 10 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
- Multi-pack with 10 boxes each containing 1 vial of 10 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
- Box with 1 vial of 50 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
- Box with 1 vial of 20 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
- Box with 1 vial 10 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
- Multi-pack with 10 boxes each containing 1 vial of 50 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
- Multi-pack with 10 boxes each containing 1 vial of 20 ml. Colourless type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap. One glass vial in a cardboard box.
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:
- Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Produlab Pharma B.V.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V540435
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0318/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
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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