Sedivet 10 mg/ml Oplossing voor injectie
Sedivet 10 mg/ml Oplossing voor injectie
Authorised
- Romifidine hydrochloride
Product identification
Medicine name:
Sedivet 10 mg/ml Oplossing voor injectie
Sedivet 10 mg/ml Solution injectable
Sedivet 10 mg/ml Injektionslösung
Active substance:
- Romifidine hydrochloride
Target species:
-
Horse
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Romifidine hydrochloride10.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
-
Horse
-
Meat and offal6day
-
Milkno withdrawal periodDo not use in animals producing milk for human consumption
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05CM93
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- Sedivet 20 ml Vial 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:
- Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- LABIANA LIFE SCIENCES, S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V156676
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
This document does not exist in this language (English). You can find it
in another language below.
Package Leaflet
This document does not exist in this language (English). You can find it
in another language below.
Labelling
This document does not exist in this language (English). You can find it
in another language below.
