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PREVENAR 20
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1875157
Name of medicinal product:
PREVENAR 20
Active substances:
Pneumococcus, purified polysaccharides antigen conjugated
Estonian
,
English
,
Latin
ATC code:
J07AL02
Dosage form:
suspension for injection in pre-filled syringe
Route of administration:
intramuscular use
Strengh:
1annus 0.5ml
Amount in package:
0.5ml 50TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Active immunisation for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants, children, and adolescents from 6 weeks to less than 18 years of age. Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. Prevenar 20 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:
Never imported to Estonia
:
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions
to State Agency of Medicines
.
State Agency of Medicines
Marketing authorization
Marketing authorization holder:
Pfizer Europe MA EEIG
Marketing authorization number:
EU/1/21/1612
Marketing authorization issued on:
February 14, 2022
Marketing authorization expires on:
February 15, 2027
Marketing authorization procedure type:
Centralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Perscription conditions and restrictions
Description
Additional condition
Ei ole lubatud väljastada korduvretsepti
Entry/Changing date: March 27, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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