Overview

The marketing authorisation for Prepandrix has been withdrawn at the request of the marketing-authorisation holder. 

Prepandrix : EPAR - Summary for the public

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polski (PL) (753.77 KB - PDF)
português (PT) (655.51 KB - PDF)
română (RO) (705.46 KB - PDF)
slovenčina (SK) (760.78 KB - PDF)
slovenščina (SL) (744.7 KB - PDF)
Suomi (FI) (655.55 KB - PDF)
svenska (SV) (677.15 KB - PDF)

Product information

Prepandrix : EPAR - Product Information

български (BG) (2.84 MB - PDF)
español (ES) (1.81 MB - PDF)
čeština (CS) (2.53 MB - PDF)
dansk (DA) (1.85 MB - PDF)
Deutsch (DE) (1.85 MB - PDF)
eesti keel (ET) (1.79 MB - PDF)
ελληνικά (EL) (2.91 MB - PDF)
français (FR) (1.85 MB - PDF)
hrvatski (HR) (1.87 MB - PDF)
íslenska (IS) (1.82 MB - PDF)
italiano (IT) (1.84 MB - PDF)
latviešu valoda (LV) (2.6 MB - PDF)
lietuvių kalba (LT) (1.94 MB - PDF)
magyar (HU) (2.51 MB - PDF)
Malti (MT) (2.61 MB - PDF)
Nederlands (NL) (1.82 MB - PDF)
norsk (NO) (1.8 MB - PDF)
polski (PL) (2.56 MB - PDF)
português (PT) (1.85 MB - PDF)
română (RO) (1.97 MB - PDF)
slovenčina (SK) (2.56 MB - PDF)
slovenščina (SL) (2.48 MB - PDF)
Suomi (FI) (1.85 MB - PDF)
svenska (SV) (1.81 MB - PDF)

Latest procedure affecting product information: IB/0077

20/09/2018

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This medicine’s product information is available in all official EU languages.
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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).

Prepandrix : EPAR - All Authorised presentations

български (BG) (706.57 KB - PDF)
español (ES) (599.09 KB - PDF)
čeština (CS) (688.89 KB - PDF)
dansk (DA) (636.44 KB - PDF)
Deutsch (DE) (599.05 KB - PDF)
eesti keel (ET) (599.16 KB - PDF)
ελληνικά (EL) (692.08 KB - PDF)
français (FR) (635.45 KB - PDF)
hrvatski (HR) (731.49 KB - PDF)
íslenska (IS) (683.46 KB - PDF)
italiano (IT) (633.94 KB - PDF)
latviešu valoda (LV) (688.77 KB - PDF)
lietuvių kalba (LT) (667.71 KB - PDF)
magyar (HU) (685.93 KB - PDF)
Malti (MT) (691.47 KB - PDF)
Nederlands (NL) (598.72 KB - PDF)
norsk (NO) (682.3 KB - PDF)
polski (PL) (687.41 KB - PDF)
português (PT) (635.96 KB - PDF)
română (RO) (671.36 KB - PDF)
slovenčina (SK) (686.86 KB - PDF)
slovenščina (SL) (614.22 KB - PDF)
Suomi (FI) (594.07 KB - PDF)
svenska (SV) (599.04 KB - PDF)

Product details

Name of medicine
Prepandrix
Active substance
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
International non-proprietary name (INN) or common name
prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
J07BB02

Pharmacotherapeutic group

Vaccines

Therapeutic indication

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 vaccine prepared with H5N1 subtype strains.

Prepandrix should be used in accordance with official guidance.

Authorisation details

EMA product number
EMEA/H/C/000822

Accelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Marketing authorisation holder
GlaxoSmithKline Biologicals S.A.

Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Marketing authorisation issued
14/05/2008
Revision
13

Assessment history

Prepandrix : EPAR - Procedural steps taken and scientific information after authorisation

Prepandrix-H-C-822-P46-0054 : EPAR - Assessment Report

Prepandrix-H-C-822-P46-0055 : EPAR - Assessment Report

Prepandrix-H-C-822-PSUV-0049 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Prepandrix-H-C-822-II-0029 : EPAR - Assessment Report - Variation

Prepandrix-H-C-822-II-0026 : EPAR - Assessment Report - Variation

Prepandrix-H-C-822-II-0005 : EPAR - Assessment Report - Variation

CHMP post-authorisation summary of positive opinion for Prepandrix

CHMP summary of positive opinion for Prepandrix

Prepandrix : EPAR - Public assessment report

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