For help on how to get the results you want, see our search tips.
399 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Withdrawn applications Remove Withdrawn applications filter
Categories
Human Remove Human filter
-
List item
Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,
, 
, Revision: 12, Authorised, Last updated: 23/04/2021
-
List item
Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 12, Authorised, Last updated: 23/04/2021
-
List item
Human medicine European public assessment report (EPAR): COVID-19 Vaccine Janssen (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, 
, Revision: 1, Authorised, Last updated: 23/04/2021
-
List item
Human medicine European public assessment report (EPAR): Obizur (updated)
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,, 
, Revision: 7, Authorised, Last updated: 23/04/2021
-
List item
Human medicine European public assessment report (EPAR): Natpar (updated)
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 9, Authorised, Last updated: 23/04/2021
-
List item
Human medicine European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) (updated)
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human
Date of authorisation: 20/05/2016,, , Revision: 7, Authorised, Last updated: 23/04/2021
-
List item
Human medicine European public assessment report (EPAR): Fasenra (updated)
benralizumab, Asthma
Date of authorisation: 08/01/2018,, Revision: 6, Authorised, Last updated: 22/04/2021
-
List item
Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, 
, Revision: 14, Authorised, Last updated: 22/04/2021
-
List item
Human medicine European public assessment report (EPAR): Ontruzant (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017,, 
, Revision: 9, Authorised, Last updated: 22/04/2021
-
List item
Human medicine European public assessment report (EPAR): Movymia (updated)
teriparatide, Osteoporosis
Date of authorisation: 11/01/2017,, , Revision: 8, Authorised, Last updated: 22/04/2021
-
List item
Human medicine European public assessment report (EPAR): Isentress (updated)
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 38, Authorised, Last updated: 22/04/2021
-
List item
Human medicine European public assessment report (EPAR): Cinryze (updated)
C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011,, Revision: 20, Authorised, Last updated: 22/04/2021
-
List item
Human medicine European public assessment report (EPAR): Synjardy (updated)
empagliflozin, metformin, Diabetes Mellitus, Type 2
Date of authorisation: 27/05/2015,, Revision: 18, Authorised, Last updated: 22/04/2021
-
List item
Human medicine European public assessment report (EPAR): Piqray (updated)
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 3, Authorised, Last updated: 21/04/2021
-
List item
Human medicine European public assessment report (EPAR): Cabometyx (updated)
cabozantinib (s)-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016,, , Revision: 10, Authorised, Last updated: 21/04/2021
-
List item
Human medicine European public assessment report (EPAR): Reblozyl (updated)
Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia
Date of authorisation: 25/06/2020,, , Revision: 1, Authorised, Last updated: 21/04/2021
-
List item
Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Hawaii/70/2019 (H1N1)pdm09-like strain (A/Nebraska/14/2019, wild type); A/Hong Kong/45/2019 (H3N2)-like strain (A/Delaware/39/2019, wild type); B/Washington/02/2019-like strain (B/Darwin/7/2019, wild type); B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 7, Authorised, Last updated: 21/04/2021
-
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: 5, Authorised, Last updated: 20/04/2021
-
List item
Human medicine European public assessment report (EPAR): Zykadia (updated)
ceritinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2015,, Revision: 14, Authorised, Last updated: 20/04/2021
-
List item
Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, , , Revision: 2, Authorised, Last updated: 19/04/2021
-
List item
Human medicine European public assessment report (EPAR): Equidacent (updated)
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,, , Revision: 2, Authorised, Last updated: 19/04/2021
-
List item
Human medicine European public assessment report (EPAR): Elebrato Ellipta (updated)
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 15/11/2017,, Revision: 8, Authorised, Last updated: 19/04/2021
-
List item
Human medicine European public assessment report (EPAR): MenQuadfi (updated)
Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 18/11/2020,, Revision: 1, Authorised, Last updated: 19/04/2021
-
List item
Human medicine European public assessment report (EPAR): Jinarc (updated)
Tolvaptan, Polycystic Kidney, Autosomal Dominant
Date of authorisation: 27/05/2015,, Revision: 15, Authorised, Last updated: 16/04/2021
-
List item
Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,, , Revision: 5, Authorised, Last updated: 16/04/2021