European public assessment reports

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This page allows you to find the European public assessment reports (EPAR) for human medicines published by the European Medicines Agency (EMA).

The EMA publishes an EPAR for every medicine granted a central marketing authorisation by the European Commission following an assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). EPARs are full scientific assessment reports of medicines authorised at a European Union level. 

Use this search to find information including a public-friendly summary in question-and-answer format and the package leaflet. You can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.

As of October 2016, EMA publishes the clinical data submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralised procedure, allowing the public to better understand the Agency’s decision-making. For more information see clinical data publication.

The Agency does not evaluate all medicines currently in use in Europe. If you cannot find the medicine you need through this search, please visit the website of your national health authority.

More information is available on the Central authorisation procedure and in EPARs: background and context.

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EPAR Search results
Name Active substance Therapeutic area Date of authorisation / refusal Additional monitoring Orphan     Has current safety alert Status
Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)

split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)

Disease Outbreaks Immunization Influenza, Human 2009-10-10           Authorised
Aflunov

influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)

Disease Outbreaks Immunization Influenza, Human 2010-11-29           Authorised
Arepanrix

split influenza virus, inactivated, containing antigen* : A/California/7/2009 (H1N1)v like strain (X-179A)

* produced in eggs

Disease Outbreaks Immunization Influenza, Human 2010-03-23           Withdrawn
Celvapan

whole virion, inactivated containing antigen: A/California/07/2009 (H1N1)v

Disease Outbreaks Immunization Influenza, Human 2009-03-04           Withdrawn
Daronrix

Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)

* produced in eggs

Disease Outbreaks Immunization Influenza, Human 2007-03-21           Withdrawn
Ebilfumin

oseltamivir

Influenza, Human 2014-05-22           Authorised
Fluenz

Reassortant influenza virus (live attenuated) of the following strains:

A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 (H3N2) like strain, B/Massachusetts/2/2012 like strain

Immunization Influenza, Human 2011-01-27           Withdrawn
Fluenz Tetra

reassortant influenza virus (live attenuated) of the following four strains:
A/California/7/2009 (H1N1)pdm09 - like strain
(A/Bolivia/559/2013, MEDI 255962)
A/Hong Kong/4801/2014 (H3N2) - like strain
(A/New Caledonia/71/2014, MEDI 263122)
B/Brisbane/60/2008 - like strain(B/Brisbane/60/2008, MEDI 228030)B/Phuket/3073/2013 - like strain(B/Phuket/3073/2013, MEDI 254977)

Influenza, Human 2013-12-04           Authorised
Focetria

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181 7.5 microgragms per 0.5 ml dose

Disease Outbreaks Immunization Influenza, Human 2007-05-02           Withdrawn
Foclivia

influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1)

Disease Outbreaks Immunization Influenza, Human 2009-10-19           Authorised
Hexacima

diphtheria toxoid / tetanus toxoid / two-component acellular pertussis (pertussis toxoid and filamentous haemagglutinin ) / inactivated poliomyelitis virus types 1,2 and 3 / Haemophilus influenzae type-b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein / hepatitis-B surface antigen

Diphtheria Hepatitis B Immunization Meningitis, Haemophilus Poliomyelitis Tetanus Whooping Cough 2013-04-17           Authorised
Hexavac

purified diphtheria toxoid / purified tetanus toxoid / purified pertussis toxoid / purified pertussis filamentous haemagglutinin / hepatitis B surface antigen / inactivated type 1 poliovirus (Mahoney) / inactivated type 2 poliovirus (MEF 1) / inactivated type 3 poliovirus (Saukett) / Haemophilus influenzae type b polysaccharide

Diphtheria Hepatitis B Immunization Meningitis, Haemophilus Poliomyelitis Tetanus Whooping Cough 2000-10-23           Withdrawn
Hexyon

diphtheria toxoid / tetanus toxoid / two-component acellular pertussis (pertussis toxoid and filamentous haemagglutinin) / inactivated poliomyelitis virus types 1, 2 and 3 / Haemophilus influenzae type-b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein / hepatitis-B surface antigen

Diphtheria Hepatitis B Immunization Meningitis, Haemophilus Poliomyelitis Tetanus Whooping Cough 2013-04-17           Authorised
Humenza

split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)

*propagated in eggs.

Disease Outbreaks Immunization Influenza, Human 2010-06-08           Withdrawn
IDflu

influenza virus (inactivated, split) of the following strains:
A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)
A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)
B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)

Immunization Influenza, Human 2009-02-24           Authorised
Infanrix Hexa

diphtheria toxoid / tetanus toxoid / Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) / hepatitis B surface antigen / poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)) / Haemophilus influenzae type-b polysaccharide

Diphtheria Hepatitis B Immunization Meningitis, Haemophilus Poliomyelitis Tetanus Whooping Cough 2000-10-23           Authorised
Intanza

influenza virus (inactivated, split) of the following strains:
A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)
A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)
B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)

Immunization Influenza, Human 2009-02-24           Authorised
Optaflu

influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:
A/California/7/2009 (H1N1)pdm09 - like strain
(A/Brisbane/10/2010, wild type)
A/Switzerland/9715293/2013 (H3N2) - like strain
(A/South Australia/55/2014, wild type)
B/Phuket/3073/2013–like strain
(B/Utah/9/2014, wild type)

Immunization Influenza, Human 2007-06-01           Withdrawn
Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)

reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain

Influenza, Human 2016-05-20           Authorised
Pandemic Influenza Vaccine H5N1 Baxter AG

influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1)

Disease Outbreaks Immunization Influenza, Human 2009-10-16           Authorised
Pandemrix

split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A

Disease Outbreaks Immunization Influenza, Human 2008-05-20           Withdrawn
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals

split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)

Disease Outbreaks Immunization Influenza, Human 2008-09-26           Withdrawn
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics

influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1)

Disease Outbreaks Immunization Influenza, Human 2010-11-29           Withdrawn
Prepandrix

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)

Disease Outbreaks Immunization Influenza, Human 2008-05-14           Authorised
Procomvax

polyribosylribitol phosphate from Haemophilus influenzae type b as PRP-OMPC / outer membrane protein complex of Neisseria meningitidis (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B) / adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae)

Hepatitis B Immunization Meningitis, Haemophilus 1999-05-07           Withdrawn