Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1506541
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Name of medicinal product:
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AFLUNOV
|
Active substances:
|
|
ATC code:
|
J07BB02
|
Dosage form:
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suspension for injection in pre-filled syringe
|
Route of administration:
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intramuscular use
|
Strengh:
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1annus 0.5ml
|
Amount in package:
|
0.5ml 10TK
|
Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
|
|
Additional information:
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|
Indication:
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Active immunisation against H5N1 subtype of Influenza A virus.
This indication is based on immunogenicity data from healthy subjects from the age of 18 years
onwards following administration of two doses of the vaccine containing
A/turkey/Turkey/1/2005 (H5N1)-like strain (see sections 4.4 and 5.1).
AFLUNOV should be used in accordance with official recommendations.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
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Never imported to Estonia
|
Marketing authorization holder:
|
Seqirus S.r.l.
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Marketing authorization number:
|
EU/1/10/658
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Marketing authorization issued on:
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November 29, 2010
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Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
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Centralised
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Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Description
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Additional condition
|
Ei ole lubatud väljastada korduvretsepti
|
|
Entry/Changing date:
February 5, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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