399 results
Categories
Human Remove Human filter
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Summaries of opinion Remove Summaries of opinion filter
Orphan designations Remove Orphan designations filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Generic Remove Generic filter
Orphan medicine Remove Orphan medicine filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Plerixafor Accord
Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation
Date of authorisation: 16/12/2022,
, 
, Revision: 1, Authorised, Last updated: 07/08/2023
-
List item
Human medicine European public assessment report (EPAR): Arikayce liposomal
Amikacin sulfate, Respiratory Tract Infections
Date of authorisation: 27/10/2020,
, Revision: 2, Authorised, Last updated: 04/08/2023
-
List item
Human medicine European public assessment report (EPAR): Capecitabine Accord
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 16, Authorised, Last updated: 03/08/2023
-
List item
Human medicine European public assessment report (EPAR): Idefirix
Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020,, , 
, Revision: 4, Authorised, Last updated: 01/08/2023
-
List item
Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,
, Revision: 24, Authorised, Last updated: 01/08/2023
-
List item
Human medicine European public assessment report (EPAR): Sogroya
Somapacitan, Growth
Date of authorisation: 31/03/2021,, , Revision: 2, Authorised, Last updated: 31/07/2023
-
List item
Human medicine European public assessment report (EPAR): Ztalmy
Ganaxolone, Epileptic Syndromes; Spasms, Infantile
Date of authorisation: 26/07/2023,, , Authorised, Last updated: 31/07/2023
-
List item
Human medicine European public assessment report (EPAR): Oprymea
pramipexole dihydrochloride monohydrate, Parkinson Disease
Date of authorisation: 12/09/2008,, Revision: 22, Authorised, Last updated: 31/07/2023
-
List item
Human medicine European public assessment report (EPAR): Luxturna
voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa
Date of authorisation: 22/11/2018,, , Revision: 7, Authorised, Last updated: 28/07/2023
-
List item
Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 5, Authorised, Last updated: 27/07/2023
-
List item
Human medicine European public assessment report (EPAR): Gefitinib Mylan
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,, Revision: 6, Authorised, Last updated: 27/07/2023
-
List item
Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,, , , Revision: 6, Authorised, Last updated: 27/07/2023
-
List item
Human medicine European public assessment report (EPAR): Revestive
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,, , Revision: 22, Authorised, Last updated: 27/07/2023
-
List item
Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan
emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016,, Revision: 14, Authorised, Last updated: 27/07/2023
-
List item
Human medicine European public assessment report (EPAR): Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)
lenalidomide hydrochloride monohydrate, Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Follicular; Lymphoma, Mantle-Cell
Date of authorisation: 11/02/2021,, Revision: 4, Authorised, Last updated: 26/07/2023
-
List item
Human medicine European public assessment report (EPAR): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 15, Authorised, Last updated: 26/07/2023
-
List item
Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Revision: 4, Authorised, Last updated: 26/07/2023
-
List item
Human medicine European public assessment report (EPAR): Miglustat Dipharma
miglustat, Gaucher Disease
Date of authorisation: 18/02/2019,, Revision: 7, Authorised, Last updated: 26/07/2023
-
List item
Human medicine European public assessment report (EPAR): Rydapt
Midostaurin, Leukemia, Myeloid, Acute; Mastocytosis
Date of authorisation: 18/09/2017,, Revision: 11, Authorised, Last updated: 26/07/2023
-
List item
Human medicine European public assessment report (EPAR): Kisplyx
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, Revision: 20, Authorised, Last updated: 25/07/2023
-
List item
Human medicine European public assessment report (EPAR): Lenvima
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, , Revision: 19, Authorised, Last updated: 25/07/2023
-
List item
Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, , Revision: 10, Authorised, Last updated: 25/07/2023
-
List item
Human medicine European public assessment report (EPAR): Nulibry
fosdenopterin hydrobromide dihydrate, Metal Metabolism, Inborn Errors
Date of authorisation: 15/09/2022,, , Revision: 2, Authorised, Last updated: 21/07/2023
-
List item
Human medicine European public assessment report (EPAR): Tavneos
Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 11/01/2022,, , Revision: 3, Authorised, Last updated: 20/07/2023
-
List item
Human medicine European public assessment report (EPAR): Givlaari
Givosiran, Porphyrias, Hepatic
Date of authorisation: 02/03/2020,, , Revision: 5, Authorised, Last updated: 19/07/2023