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COMIRNATY ORIGINAL/OMICRON BA.1
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1887947
Name of medicinal product:
COMIRNATY ORIGINAL/OMICRON BA.1
Active substances:
COVID-19, RNA-based vaccine
Estonian
,
English
,
Latin
ATC code:
J07BN01
Dosage form:
dispersion for injection
Route of administration:
intramuscular use
Strengh:
6annus 2.25ml
Amount in package:
2.25ml 195TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19 (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recommendations.
Safety features:
Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL):
EST
Translation of package information leaflet into Russian:
RUS
(last updated November 21, 2023)
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:
BioNTech Manufacturing GmbH
Marketing authorization number:
EU/1/20/1528
Marketing authorization issued on:
December 21, 2020
Marketing authorization expires on:
October 10, 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: September 19, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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