Pumarix
Withdrawn
This medicine's authorisation has been withdrawn
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Pumarix has been withdrawn at the request of the marketing authorisation holder.
Pumarix : EPAR - Summary for the public
English (EN) (531.02 KB - PDF)
First published: Last updated:
български (BG) (692.36 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
español (ES) (529.54 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
čeština (CS) (600.19 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
dansk (DA) (595.85 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Deutsch (DE) (528.89 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
eesti keel (ET) (533.1 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
ελληνικά (EL) (650.19 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
français (FR) (534.38 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
italiano (IT) (531.26 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
latviešu valoda (LV) (603.03 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
lietuvių kalba (LT) (557.85 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
magyar (HU) (591.33 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Malti (MT) (599.66 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Nederlands (NL) (527.64 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
polski (PL) (598.29 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
português (PT) (526.78 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
română (RO) (559.5 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
slovenčina (SK) (595.73 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
slovenščina (SL) (586.97 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Suomi (FI) (533.09 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
svenska (SV) (525.66 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Product information
Pumarix : EPAR - Product Information
English (EN) (1000.31 KB - PDF)
First published: Last updated:
български (BG) (1.86 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
español (ES) (1015.8 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
čeština (CS) (1.56 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
dansk (DA) (989.86 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Deutsch (DE) (1022.96 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
eesti keel (ET) (1.01 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
ελληνικά (EL) (1.94 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
français (FR) (1.01 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
hrvatski (HR) (1.07 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
íslenska (IS) (1017.39 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
italiano (IT) (1009.37 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
latviešu valoda (LV) (1.62 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
lietuvių kalba (LT) (1.05 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
magyar (HU) (1.58 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Malti (MT) (1.65 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Nederlands (NL) (1 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
norsk (NO) (993.36 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
polski (PL) (1.54 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
português (PT) (998.18 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
română (RO) (1.14 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
slovenčina (SK) (1.6 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
slovenščina (SL) (1.55 MB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Suomi (FI) (1010.24 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
svenska (SV) (998.99 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Latest procedure affecting product information:
P46/0016
28/02/2014
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
English (EN) (506.53 KB - PDF)
First published: Last updated:
български (BG) (564.77 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
español (ES) (507.55 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
čeština (CS) (554.2 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
dansk (DA) (508.21 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Deutsch (DE) (472.1 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
eesti keel (ET) (472.43 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
ελληνικά (EL) (560.58 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
français (FR) (507.54 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
íslenska (IS) (509.07 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
italiano (IT) (505.99 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
latviešu valoda (LV) (552.38 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
lietuvių kalba (LT) (540.26 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
magyar (HU) (548.91 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Malti (MT) (561 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Nederlands (NL) (473.05 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
norsk (NO) (472.2 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
polski (PL) (557.67 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
português (PT) (472.3 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
română (RO) (542.51 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
slovenčina (SK) (556.72 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
slovenščina (SL) (518.95 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
Suomi (FI) (467.38 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
svenska (SV) (472.7 KB - PDF)
First published: 05/04/2011Last updated: 17/03/2015
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
VaccinesTherapeutic 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.
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
English (EN) (569.11 KB - PDF)
First published: Last updated:
Pumarix-H-C-1212-P46-0016 : EPAR - Assessment Report
AdoptedReference Number: EMA/711988/2014
English (EN) (1.33 MB - PDF)
First published: Last updated:
Pumarix-H-C-1212-PSUV-0009 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/265942/2014
English (EN) (524.86 KB - PDF)
First published: Last updated:
More information on Pumarix
Public statement on Pumarix: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/475613/2014
English (EN) (66.95 KB - PDF)
First published: Last updated:
More information on Pumarix
This page was last updated on