For help on how to get the results you want, see our search tips.
59 results
Keyword Remove keyword
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Additional monitoring Remove Additional monitoring filter
Exceptional circumstances Remove Exceptional circumstances filter
Biosimilar Remove Biosimilar filter
Medicine
Summaries of opinion Remove Summaries of opinion filter
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Categories
Human Remove Human filter
-
List item
Human medicine European public assessment report (EPAR): Olysio
simeprevir, Hepatitis C, Chronic
Date of authorisation: 14/05/2014,, Revision: 13, Withdrawn, Last updated: 23/05/2018
-
List item
Human medicine European public assessment report (EPAR): Onsenal
Celecoxib, Adenomatous Polyposis Coli
Date of authorisation: 17/10/2003,, Revision: 13, Withdrawn, Last updated: 06/04/2011
-
List item
Human medicine European public assessment report (EPAR): Picato
Ingenol mebutate, Keratosis, Actinic
Date of authorisation: 15/11/2012,, Revision: 10, Withdrawn, Last updated: 31/07/2020
-
List item
Human medicine European public assessment report (EPAR): Portrazza
necitumumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 15/02/2016,, Revision: 3, Withdrawn, Last updated: 27/07/2021
-
List item
Human medicine European public assessment report (EPAR): Prepandrix
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 14/05/2008,, Revision: 13, Withdrawn, Last updated: 23/02/2021
-
List item
Human medicine European public assessment report (EPAR): Provenge
autologous peripheral-blood mononuclear cells including a minimum of 50 million autologous CD54+ cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor, Prostatic Neoplasms
Date of authorisation: 06/09/2013,, Revision: 1, Withdrawn, Last updated: 19/05/2015
-
List item
Human medicine European public assessment report (EPAR): Pumarix
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) , Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 04/03/2011,, Revision: 4, Withdrawn, Last updated: 17/03/2015
-
List item
Human medicine European public assessment report (EPAR): Qutavina
teriparatide, Osteoporosis
Date of authorisation: 27/08/2020,, Withdrawn, Last updated: 18/01/2021
-
List item
Human medicine European public assessment report (EPAR): Raplixa
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 19/03/2015,, Revision: 6, Withdrawn, Last updated: 10/10/2018
-
List item
Human medicine European public assessment report (EPAR): Rienso
Ferumoxytol, Anemia; Kidney Failure, Chronic
Date of authorisation: 15/06/2012,, Revision: 7, Withdrawn, Last updated: 13/07/2015
-
List item
Human medicine European public assessment report (EPAR): Rilonacept Regeneron (previously Arcalyst)
Rilonacept, Cryopyrin-Associated Periodic Syndromes
Date of authorisation: 23/10/2009,, Revision: 5, Withdrawn, Last updated: 30/10/2012
-
List item
Human medicine European public assessment report (EPAR): Ristempa
pegfilgrastim, Neutropenia
Date of authorisation: 13/04/2015,, Revision: 3, Withdrawn, Last updated: 07/03/2018
-
List item
Human medicine European public assessment report (EPAR): Ritemvia
rituximab, Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 13/07/2017,,
, Revision: 8, Withdrawn, Last updated: 16/08/2021
-
List item
Human medicine European public assessment report (EPAR): Rituzena (previously Tuxella)
rituximab, Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis
Date of authorisation: 13/07/2017,,
, Revision: 7, Withdrawn, Last updated: 08/07/2019
-
List item
Human medicine European public assessment report (EPAR): Skysona
elivaldogene autotemcel, Adrenoleukodystrophy
Date of authorisation: 16/07/2021,, Withdrawn, Last updated: 04/04/2022
-
List item
Human medicine European public assessment report (EPAR): Solumarv
insulin human, Diabetes Mellitus
Date of refusal: 11/02/2016,, Refused, Last updated: 16/02/2016
-
List item
Human medicine European public assessment report (EPAR): Solymbic
adalimumab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Hidradenitis Suppurativa; Psoriasis; Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,,
, Revision: 2, Withdrawn, Last updated: 05/03/2019
-
List item
Human medicine European public assessment report (EPAR): Staquis
Crisaborole, Dermatitis, Atopic
Date of authorisation: 27/03/2020,, Revision: 6, Withdrawn, Last updated: 08/02/2022
-
List item
Human medicine European public assessment report (EPAR): Temybric Ellipta
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 12/06/2019,, Revision: 4, Withdrawn, Last updated: 24/11/2022
-
List item
Human medicine European public assessment report (EPAR): Thorinane
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 14/09/2016,,
, Revision: 2, Withdrawn, Last updated: 24/10/2019
-
List item
Human medicine European public assessment report (EPAR): Trogarzo (updated)
Ibalizumab, HIV Infections
Date of authorisation: 26/09/2019,, Revision: 7, Withdrawn, Last updated: 16/01/2023
-
List item
Human medicine European public assessment report (EPAR): Truberzi
eluxadoline, Irritable Bowel Syndrome; Diarrhea
Date of authorisation: 19/09/2016,, Revision: 6, Withdrawn, Last updated: 25/02/2021
-
List item
Human medicine European public assessment report (EPAR): Turalio
Pexidartinib, Giant Cell Tumor of Tendon Sheath; Synovitis, Pigmented Villonodular
Date of refusal: 28/10/2020,,
, Refused, Last updated: 18/12/2020
-
List item
Human medicine European public assessment report (EPAR): Udenyca
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,,
, Revision: 3, Withdrawn, Last updated: 15/02/2021
-
List item
Human medicine European public assessment report (EPAR): Valtropin
somatropin, Turner Syndrome; Dwarfism, Pituitary
Date of authorisation: 24/04/2006,, Revision: 5, Withdrawn, Last updated: 14/08/2012