For help on how to get the results you want, see our search tips.
97 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Orphan designations Remove Orphan designations filter
Summaries of opinion Remove Summaries of opinion filter
Referrals Remove Referrals filter
Withdrawn applications Remove Withdrawn applications filter
Categories
Human Remove Human filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Generic Remove Generic filter
Conditional approval Remove Conditional approval filter
Orphan medicine Remove Orphan medicine filter
Additional monitoring Remove Additional monitoring filter
Authorisation status
Withdrawn Remove Withdrawn filter
-
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, Revision: 3, Withdrawn, Last updated: 15/02/2021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): Halimatoz
adalimumab, Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 8, Withdrawn, Last updated: 29/01/2021
-
List item
Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm GmbH
clopidogrel, Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/07/2009,
, Revision: 12, Withdrawn, Last updated: 25/01/2021
-
List item
Human medicine European public assessment report (EPAR): Alpivab
Peramivir, Influenza, Human
Date of authorisation: 13/04/2018,, Revision: 2, Withdrawn, Last updated: 09/12/2020
-
List item
Human medicine European public assessment report (EPAR): Ribavirin Mylan (previously Ribavirin Three Rivers)
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 10/06/2010,, Revision: 10, Withdrawn, Last updated: 23/11/2020
-
List item
Human medicine European public assessment report (EPAR): Zurampic
lesinurad, Hyperuricemia
Date of authorisation: 18/02/2016,, Revision: 4, Withdrawn, Last updated: 31/07/2020
-
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Date of authorisation: 15/11/2012,, Revision: 10, Withdrawn, Last updated: 31/07/2020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): Kromeya
adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Psoriasis; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Colitis, Ulcerative; Crohn Disease
Date of authorisation: 02/04/2019,, , Revision: 4, Withdrawn, Last updated: 25/03/2020
-
List item
Human medicine European public assessment report (EPAR): Varuby
rolapitant, Vomiting; Nausea; Cancer
Date of authorisation: 19/04/2017,, Revision: 3, Withdrawn, Last updated: 02/03/2020
-
List item
Human medicine European public assessment report (EPAR): Iblias
octocog alfa, Hemophilia A
Date of authorisation: 18/02/2016,, Revision: 4, Withdrawn, Last updated: 18/02/2020
-
List item
Human medicine European public assessment report (EPAR): Zalmoxis
Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2), Hematopoietic Stem Cell Transplantation; Graft vs Host Disease
Date of authorisation: 18/08/2016,
, Revision: 1, Withdrawn, Last updated: 14/02/2020
-
List item
Human medicine European public assessment report (EPAR): Fexeric
ferric citrate coordination complex, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 23/09/2015,, Revision: 2, Withdrawn, Last updated: 04/02/2020
-
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): Imatinib medac
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome
Date of authorisation: 25/09/2013,, Revision: 5, Withdrawn, Last updated: 16/10/2019
-
List item
Human medicine European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited )
docetaxel trihydrate, Stomach Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 28/08/2015,, Revision: 8, Withdrawn, Last updated: 15/10/2019
-
List item
Human medicine European public assessment report (EPAR): Lartruvo
Olaratumab, Sarcoma
Date of authorisation: 09/11/2016,, 
, , Revision: 3, Withdrawn, Last updated: 02/09/2019
-
List item
Human medicine European public assessment report (EPAR): Daklinza
daclatasvir dihydrochloride, Hepatitis C, Chronic
Date of authorisation: 22/08/2014,, Revision: 15, Withdrawn, Last updated: 30/08/2019
-
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): ATryn
Antithrombin alfa, Antithrombin III Deficiency
Date of authorisation: 28/07/2006,, 
, Revision: 16, Withdrawn, Last updated: 02/07/2019
-
List item
Human medicine European public assessment report (EPAR): Topotecan Actavis
topotecan, Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 24/07/2009,, Revision: 6, Withdrawn, Last updated: 07/03/2019
-
List item
Human medicine European public assessment report (EPAR): Cyltezo
adalimumab, Hidradenitis Suppurativa; Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 10/11/2017,, , Revision: 2, Withdrawn, Last updated: 06/03/2019
-
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): Ivabradine JensonR
ivabradine hydrochloride, Angina Pectoris; Heart Failure
Date of authorisation: 11/11/2016,, Withdrawn, Last updated: 20/12/2018
-
List item
Human medicine European public assessment report (EPAR): Zoledronic acid Teva Pharma
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/08/2012,, Revision: 11, Withdrawn, Last updated: 12/12/2018
-
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