Product class:
|
Authorized package
|
Medicinal product class:
|
Veterinary medicine
|
Package code:
|
1807163
|
Name of medicinal product:
|
Nobivac Myxo-RHD PLUS
|
Active substances:
|
|
ATC code:
|
QI08AD80
|
Dosage form:
|
lyophilisate and solvent for suspension for injection
|
Route of administration:
|
subcutaneous use
|
Strengh:
|
|
Amount in package:
|
0.5ml 5TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs
of myxomatosis and rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV1) and
RHD type 2 virus (RHDV2).
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
|
Safety features:
|
No
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Withdrawal time:
|
|
Species:
|
küülik
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Intervet International B.V.
|
Marketing authorization number:
|
EU/2/19/244
|
Marketing authorization issued on:
|
November 19, 2019
|
Marketing authorization expires on:
|
November 21, 2024
|
Marketing authorization procedure type:
|
Centralised
|
Entry/Changing date:
December 2, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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