PreHevbri

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Withdrawn

This medicine's authorisation has been withdrawn

hepatitis B surface antigen
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for PreHevbri (SRD) has been withdrawn at the request of the marketing-authorisation holder.

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Product information

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Latest procedure affecting product information: IB/0008
25/11/2024
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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čeština (CS) (124.24 KB - PDF)

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dansk (DA) (82.94 KB - PDF)

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Deutsch (DE) (83.71 KB - PDF)

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eesti keel (ET) (80.28 KB - PDF)

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français (FR) (81.18 KB - PDF)

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hrvatski (HR) (119.53 KB - PDF)

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italiano (IT) (80.03 KB - PDF)

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latviešu valoda (LV) (101.25 KB - PDF)

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lietuvių kalba (LT) (103.81 KB - PDF)

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slovenčina (SK) (123.83 KB - PDF)

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slovenščina (SL) (118.74 KB - PDF)

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Suomi (FI) (80.16 KB - PDF)

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svenska (SV) (101.76 KB - PDF)

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Product details

Name of medicine
PreHevbri
Active substance
hepatitis B surface antigen
International non-proprietary name (INN) or common name
hepatitis B surface antigen
Therapeutic area (MeSH)
Hepatitis B
Anatomical therapeutic chemical (ATC) code
J07BC01

Pharmacotherapeutic group

Vaccines

Therapeutic indication

PreHevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis B virus in adults.

It can be expected that hepatitis D will also be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

The use of PreHevbri should be in accordance with official recommendations.

Authorisation details

EMA product number
EMEA/H/C/005466
Marketing authorisation holder
VBI Vaccines B.V.

Queen’s Tower Office Number 714
Delflandlaan 1
1062 EA
Amsterdam
Netherlands

Opinion adopted
24/02/2022
Marketing authorisation issued
25/04/2022
Revision
3

Assessment history

This page was last updated on

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