For help on how to get the results you want, see our search tips.
511 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Withdrawn applications Remove Withdrawn applications filter
Summaries of opinion Remove Summaries of opinion filter
Orphan designations Remove Orphan designations filter
Medicine type
Additional monitoring Remove Additional monitoring filter
Biosimilar Remove Biosimilar filter
Categories
Human Remove Human filter
-
List item
Human medicine European public assessment report (EPAR): Xeljanz (updated)
tofacitinib citrate, Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,
Date of refusal: 25/04/2013,
, 
, Revision: 16, Authorised, Last updated: 28/01/2021
-
List item
Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck
Date of authorisation: 17/07/2015,, Revision: 31, Authorised, Last updated: 28/01/2021
-
List item
Human medicine European public assessment report (EPAR): Zynteglo (updated)
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, 
, 
, 
, Revision: 3, Authorised, Last updated: 28/01/2021
-
List item
Human medicine European public assessment report (EPAR): Lorviqua (updated)
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,, , Revision: 5, Authorised, Last updated: 28/01/2021
-
List item
Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, , Revision: 2, Authorised, Last updated: 28/01/2021
-
List item
Human medicine European public assessment report (EPAR): Doptelet (updated)
avatrombopag maleate, Thrombocytopenia
Date of authorisation: 20/06/2019,, Revision: 3, Authorised, Last updated: 28/01/2021
-
List item
Human medicine European public assessment report (EPAR): Strimvelis (updated)
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016,, , Revision: 5, Authorised, Last updated: 28/01/2021
-
List item
Human medicine European public assessment report (EPAR): Piqray (updated)
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 1, Authorised, Last updated: 28/01/2021
-
List item
Human medicine European public assessment report (EPAR): Coagadex (updated)
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,, , , Revision: 6, Authorised, Last updated: 27/01/2021
-
List item
Human medicine European public assessment report (EPAR): Alunbrig (updated)
brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018,, Revision: 5, Authorised, Last updated: 27/01/2021
-
List item
Human medicine European public assessment report (EPAR): Lojuxta (updated)
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,, 
, Revision: 13, Authorised, Last updated: 27/01/2021
-
List item
Human medicine European public assessment report (EPAR): Lutathera (updated)
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, , Revision: 4, Authorised, Last updated: 27/01/2021
-
List item
Human medicine European public assessment report (EPAR): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, , , Revision: 15, Authorised, Last updated: 26/01/2021
-
List item
Human medicine European public assessment report (EPAR): Tecentriq (updated)
atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Urologic Neoplasms, Breast Neoplasms, Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017,, Revision: 12, Authorised, Last updated: 26/01/2021
-
List item
Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,, , Authorised, Last updated: 26/01/2021
-
List item
Human medicine European public assessment report (EPAR): Takhzyro (updated)
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 4, Authorised, Last updated: 25/01/2021
-
List item
Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , , Revision: 8, Authorised, Last updated: 25/01/2021
-
List item
Human medicine European public assessment report (EPAR): Ocrevus (updated)
ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018,, Revision: 9, Authorised, Last updated: 22/01/2021
-
List item
Human medicine European public assessment report (EPAR): Symkevi (updated)
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,, , Revision: 7, Authorised, Last updated: 22/01/2021
-
List item
Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic
Date of authorisation: 27/09/2017,, Revision: 9, Authorised, Last updated: 22/01/2021
-
List item
Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 11, Authorised, Last updated: 22/01/2021
-
List item
Human medicine European public assessment report (EPAR): Tremfya (updated)
guselkumab, Psoriasis
Date of authorisation: 10/11/2017,, Revision: 5, Authorised, Last updated: 22/01/2021
-
List item
Human medicine European public assessment report (EPAR): Ervebo (updated)
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019,, Revision: 2, Authorised, Last updated: 22/01/2021
-
List item
Human medicine European public assessment report (EPAR): Wakix (updated)
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, , Revision: 9, Authorised, Last updated: 21/01/2021
-
List item
Human medicine European public assessment report (EPAR): Mysimba (updated)
bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight
Date of authorisation: 26/03/2015,, Revision: 18, Authorised, Last updated: 21/01/2021