Overview

The marketing authorisation for Pumarix has been withdrawn at the request of the marketing authorisation holder.

Pumarix : EPAR - Summary for the public

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magyar (HU) (591.33 KB - PDF)
Malti (MT) (599.66 KB - PDF)
Nederlands (NL) (527.64 KB - PDF)
polski (PL) (598.29 KB - PDF)
português (PT) (526.78 KB - PDF)
română (RO) (559.5 KB - PDF)
slovenčina (SK) (595.73 KB - PDF)
slovenščina (SL) (586.97 KB - PDF)
Suomi (FI) (533.09 KB - PDF)
svenska (SV) (525.66 KB - PDF)

Product information

Pumarix : EPAR - Product Information

български (BG) (1.86 MB - PDF)
español (ES) (1015.8 KB - PDF)
čeština (CS) (1.56 MB - PDF)
dansk (DA) (989.86 KB - PDF)
Deutsch (DE) (1022.96 KB - PDF)
eesti keel (ET) (1.01 MB - PDF)
ελληνικά (EL) (1.94 MB - PDF)
français (FR) (1.01 MB - PDF)
hrvatski (HR) (1.07 MB - PDF)
íslenska (IS) (1017.39 KB - PDF)
italiano (IT) (1009.37 KB - PDF)
latviešu valoda (LV) (1.62 MB - PDF)
lietuvių kalba (LT) (1.05 MB - PDF)
magyar (HU) (1.58 MB - PDF)
Malti (MT) (1.65 MB - PDF)
Nederlands (NL) (1 MB - PDF)
norsk (NO) (993.36 KB - PDF)
polski (PL) (1.54 MB - PDF)
português (PT) (998.18 KB - PDF)
română (RO) (1.14 MB - PDF)
slovenčina (SK) (1.6 MB - PDF)
slovenščina (SL) (1.55 MB - PDF)
Suomi (FI) (1010.24 KB - PDF)
svenska (SV) (998.99 KB - PDF)

Latest procedure affecting product information: P46/0016

28/02/2014

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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).

Pumarix : EPAR - All Authorised presentations

български (BG) (564.77 KB - PDF)
español (ES) (507.55 KB - PDF)
čeština (CS) (554.2 KB - PDF)
dansk (DA) (508.21 KB - PDF)
Deutsch (DE) (472.1 KB - PDF)
eesti keel (ET) (472.43 KB - PDF)
ελληνικά (EL) (560.58 KB - PDF)
français (FR) (507.54 KB - PDF)
íslenska (IS) (509.07 KB - PDF)
italiano (IT) (505.99 KB - PDF)
latviešu valoda (LV) (552.38 KB - PDF)
lietuvių kalba (LT) (540.26 KB - PDF)
magyar (HU) (548.91 KB - PDF)
Malti (MT) (561 KB - PDF)
Nederlands (NL) (473.05 KB - PDF)
norsk (NO) (472.2 KB - PDF)
polski (PL) (557.67 KB - PDF)
português (PT) (472.3 KB - PDF)
română (RO) (542.51 KB - PDF)
slovenčina (SK) (556.72 KB - PDF)
slovenščina (SL) (518.95 KB - PDF)
Suomi (FI) (467.38 KB - PDF)
svenska (SV) (472.7 KB - PDF)

Product details

Name of medicine
Pumarix
Active substance
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 
International non-proprietary name (INN) or common name
pandemic 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

Prophylaxis of influenza in an officially declared pandemic situation.

Pandemic-influenza vaccine should be used in accordance with official guidance.

Authorisation details

EMA product number
EMEA/H/C/001212

Exceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Marketing authorisation holder
GlaxoSmithKline Biologicals S.A. 

GlaxoSmithKline Biologicals S.A.
89, rue de l'Institut
B-1330 Rixensart
Belgium

Marketing authorisation issued
04/03/2011
Revision
4

Assessment history

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

Pumarix-H-C-1212-P46-0016 : EPAR - Assessment Report

Pumarix-H-C-1212-PSUV-0009 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Pumarix : EPAR - Public assessment report

CHMP summary of positive opinion for Pumarix

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