- 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The marketing authorisation for PreHevbri (SRD) has been withdrawn at the request of the marketing-authorisation holder.
PreHevbri : EPAR - Medicine Overview
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čeština (CS) (233.27 KB - PDF)
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eesti keel (ET) (178.28 KB - PDF)
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Malti (MT) (247.29 KB - PDF)
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polski (PL) (240.27 KB - PDF)
português (PT) (193.14 KB - PDF)
română (RO) (234.8 KB - PDF)
slovenčina (SK) (234.63 KB - PDF)
slovenščina (SL) (221.73 KB - PDF)
Suomi (FI) (188.04 KB - PDF)
svenska (SV) (186.28 KB - PDF)
PreHevbri : EPAR - Risk management plan summary
English (EN) (216.19 KB - PDF)
Product information
PreHevbri : EPAR - Product Information
English (EN) (975.75 KB - PDF)
български (BG) (1.23 MB - PDF)
español (ES) (1.01 MB - PDF)
čeština (CS) (1.1 MB - PDF)
dansk (DA) (1010.23 KB - PDF)
Deutsch (DE) (1.05 MB - PDF)
eesti keel (ET) (967.74 KB - PDF)
ελληνικά (EL) (1.28 MB - PDF)
français (FR) (1.01 MB - PDF)
hrvatski (HR) (1.11 MB - PDF)
íslenska (IS) (963.89 KB - PDF)
italiano (IT) (1003.4 KB - PDF)
latviešu valoda (LV) (1.09 MB - PDF)
lietuvių kalba (LT) (1.13 MB - PDF)
magyar (HU) (1.21 MB - PDF)
Malti (MT) (1.19 MB - PDF)
Nederlands (NL) (1.01 MB - PDF)
norsk (NO) (1007.88 KB - PDF)
polski (PL) (1.19 MB - PDF)
português (PT) (975.02 KB - PDF)
română (RO) (1.17 MB - PDF)
slovenčina (SK) (1.09 MB - PDF)
slovenščina (SL) (1.1 MB - PDF)
Suomi (FI) (982.05 KB - PDF)
svenska (SV) (986.28 KB - PDF)
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).
PreHevbri : EPAR - All authorised presentations
English (EN) (81.34 KB - PDF)
български (BG) (95.33 KB - PDF)
español (ES) (102.02 KB - PDF)
čeština (CS) (124.24 KB - PDF)
dansk (DA) (82.94 KB - PDF)
Deutsch (DE) (83.71 KB - PDF)
eesti keel (ET) (80.28 KB - PDF)
ελληνικά (EL) (124.2 KB - PDF)
français (FR) (81.18 KB - PDF)
hrvatski (HR) (119.53 KB - PDF)
íslenska (IS) (82.29 KB - PDF)
italiano (IT) (80.03 KB - PDF)
latviešu valoda (LV) (101.25 KB - PDF)
lietuvių kalba (LT) (103.81 KB - PDF)
magyar (HU) (119.82 KB - PDF)
Malti (MT) (104.6 KB - PDF)
Nederlands (NL) (80.99 KB - PDF)
norsk (NO) (81.84 KB - PDF)
polski (PL) (106.5 KB - PDF)
português (PT) (82.51 KB - PDF)
română (RO) (101.49 KB - PDF)
slovenčina (SK) (123.83 KB - PDF)
slovenščina (SL) (118.74 KB - PDF)
Suomi (FI) (80.16 KB - PDF)
svenska (SV) (101.76 KB - PDF)
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
VaccinesTherapeutic 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
PreHevbri : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (227.98 KB - PDF)
News on PreHevbri
More information on PreHevbri
Public statement on PreHevbri : Withdrawal of the marketing authorisation in the European Union
English (EN) (107.63 KB - PDF)