For help on how to get the results you want, see our search tips.
664 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Orphan designations Remove Orphan designations filter
Paediatric investigation plans Remove Paediatric investigation plans filter
-
List item
Human medicine European public assessment report (EPAR): Zynlonta (updated)
loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022,
, 
, Authorised, Last updated: 26/01/2023
-
List item
Human medicine European public assessment report (EPAR): Fingolimod Mylan (updated)
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021,
, Revision: 3, Authorised, Last updated: 26/01/2023
-
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: 9, Authorised, Last updated: 25/01/2023
-
List item
Human medicine European public assessment report (EPAR): Tabrecta (updated)
capmatinib dihydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/06/2022,, Revision: 1, Authorised, Last updated: 25/01/2023
-
List item
Human medicine European public assessment report (EPAR): Dexmedetomidine Accord (updated)
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 25/01/2023
-
List item
Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018,, 
, Revision: 18, Authorised, Last updated: 25/01/2023
-
List item
Human medicine European public assessment report (EPAR): NexoBrid (updated)
proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012,, , Revision: 14, Authorised, Last updated: 25/01/2023
-
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: 37, Authorised, Last updated: 25/01/2023
-
List item
Human medicine European public assessment report (EPAR): Besremi (updated)
ropeginterferon alfa-2b, Polycythemia Vera
Date of authorisation: 15/02/2019,, Revision: 4, Authorised, Last updated: 25/01/2023
-
List item
Human medicine European public assessment report (EPAR): Beovu (updated)
brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 25/01/2023
-
List item
Human medicine European public assessment report (EPAR): Trecondi (updated)
Treosulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 20/06/2019,, Revision: 3, Authorised, Last updated: 25/01/2023
-
List item
Human medicine European public assessment report (EPAR): Pelgraz (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, , Revision: 8, Authorised, Last updated: 23/01/2023
-
List item
Human medicine European public assessment report (EPAR): Alecensa (updated)
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,, Revision: 13, Authorised, Last updated: 23/01/2023
-
List item
Human medicine European public assessment report (EPAR): Filsuvez (updated)
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,, Revision: 1, Authorised, Last updated: 23/01/2023
-
List item
Human medicine European public assessment report (EPAR): Trepulmix (updated)
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,, Revision: 3, Authorised, Last updated: 23/01/2023
-
List item
Human medicine European public assessment report (EPAR): Dasatinib Accord (updated)
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Authorised, Last updated: 20/01/2023
-
List item
Human medicine European public assessment report (EPAR): Xofluza (updated)
Baloxavir marboxil, Influenza, Human
Date of authorisation: 07/01/2021,, Revision: 4, Authorised, Last updated: 19/01/2023
-
List item
Human medicine European public assessment report (EPAR): Pemetrexed Baxter (updated)
pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 09/12/2022,, Authorised, Last updated: 19/01/2023
-
List item
Human medicine European public assessment report (EPAR): Sarclisa (updated)
Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020,, Revision: 6, Authorised, Last updated: 18/01/2023
-
List item
Human medicine European public assessment report (EPAR): Venclyxto (updated)
Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 04/12/2016,, Revision: 15, Authorised, Last updated: 18/01/2023
-
List item
Human medicine European public assessment report (EPAR): Benlysta (updated)
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,, Revision: 29, Authorised, Last updated: 18/01/2023
-
List item
Human medicine European public assessment report (EPAR): Pirfenidone Viatris (updated)
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 10/01/2023,, Authorised, Last updated: 17/01/2023
-
List item
Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 15, Authorised, Last updated: 17/01/2023
-
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: 7, Authorised, Last updated: 17/01/2023
-
List item
Human medicine European public assessment report (EPAR): Olanzapine Mylan (updated)
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 06/10/2008,, Revision: 18, Authorised, Last updated: 17/01/2023