Product class:
|
Authorized package
|
Medicinal product class:
|
Veterinary medicine
|
Package code:
|
1859788
|
Name of medicinal product:
|
Fatrovax RHD
|
Active substances:
|
|
ATC code:
|
QI08AA01
|
Dosage form:
|
suspension for injection
|
Route of administration:
|
subcutaneous use
|
Strengh:
|
1annus 0.5ml
|
Amount in package:
|
25ml 1TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
For active immunisation of rabbits from the age of 28 days to reduce mortality, infection,
clinical signs and organ lesions of rabbit haemorrhagic disease caused by RHDV1 and
RHDV2.
|
Safety features:
|
No
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Withdrawal time:
|
|
Species:
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Fatro S.p.A.
|
Marketing authorization number:
|
EU/2/21/275
|
Marketing authorization issued on:
|
August 16, 2021
|
Marketing authorization expires on:
|
August 17, 2026
|
Marketing authorization procedure type:
|
Centralised
|
Entry/Changing date:
September 6, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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