For help on how to get the results you want, see our search tips.
231 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Orphan designations Remove Orphan designations filter
Referrals Remove Referrals filter
Categories
Human Remove Human filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Exceptional circumstances Remove Exceptional circumstances filter
Orphan medicine Remove Orphan medicine filter
Biosimilar Remove Biosimilar filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Libmyris (updated)
adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Hidradenitis Suppurativa; Crohn Disease; Colitis, Ulcerative; Uveitis
Date of authorisation: 12/11/2021,
, Authorised, Last updated: 18/01/2022
-
List item
Human medicine European public assessment report (EPAR): Hukyndra (updated)
adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 16/11/2021,, Authorised, Last updated: 18/01/2022
-
List item
Human medicine European public assessment report (EPAR): Zytiga (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,
, Revision: 23, Authorised, Last updated: 17/01/2022
-
List item
Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018,
, , Revision: 14, Authorised, Last updated: 14/01/2022
-
List item
Human medicine European public assessment report (EPAR): Movymia (updated)
teriparatide, Osteoporosis
Date of authorisation: 11/01/2017,, Revision: 10, Authorised, Last updated: 14/01/2022
-
List item
Human medicine European public assessment report (EPAR): Semglee (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,, , Revision: 6, Authorised, Last updated: 14/01/2022
-
List item
Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012,
, Revision: 13, Authorised, Last updated: 14/01/2022
-
List item
Human medicine European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane) (updated)
Para-aminosalicylic acid, Tuberculosis
Date of authorisation: 07/04/2014,, Revision: 9, Authorised, Last updated: 13/01/2022
-
List item
Human medicine European public assessment report (EPAR): Elzonris (updated)
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , 
, Revision: 3, Authorised, Last updated: 13/01/2022
-
List item
Human medicine European public assessment report (EPAR): Artesunate Amivas (updated)
artesunate, Malaria
Date of authorisation: 22/11/2021,, , Authorised, Last updated: 13/01/2022
-
List item
Human medicine European public assessment report (EPAR): Hulio (updated)
adalimumab, Hidradenitis Suppurativa; Psoriasis; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic
Date of authorisation: 17/09/2018,, , Revision: 10, Authorised, Last updated: 12/01/2022
-
List item
Human medicine European public assessment report (EPAR): Scenesse (updated)
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,, , , Revision: 8, Authorised, Last updated: 12/01/2022
-
List item
Human medicine European public assessment report (EPAR): Ogivri (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 12/12/2018,, , Revision: 8, Authorised, Last updated: 12/01/2022
-
List item
Human medicine European public assessment report (EPAR): Revestive (updated)
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,, , Revision: 17, Authorised, Last updated: 11/01/2022
-
List item
Human medicine European public assessment report (EPAR): Increlex (updated)
Mecasermin, Laron Syndrome
Date of authorisation: 02/08/2007,, , Revision: 24, Authorised, Last updated: 11/01/2022
-
List item
Human medicine European public assessment report (EPAR): Minjuvi (updated)
Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021,, , 
, Revision: 2, Authorised, Last updated: 11/01/2022
-
List item
Human medicine European public assessment report (EPAR): Deltyba (updated)
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 18, Authorised, Last updated: 11/01/2022
-
List item
Human medicine European public assessment report (EPAR): Cerdelga (updated)
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,, , Revision: 13, Authorised, Last updated: 11/01/2022
-
List item
Human medicine European public assessment report (EPAR): Prevymis (updated)
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, , Revision: 10, Authorised, Last updated: 10/01/2022
-
List item
Human medicine European public assessment report (EPAR): Grastofil (updated)
filgrastim, Neutropenia
Date of authorisation: 17/10/2013,, Revision: 14, Authorised, Last updated: 10/01/2022
-
List item
Human medicine European public assessment report (EPAR): Mvabea (updated)
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,, , Revision: 2, Authorised, Last updated: 10/01/2022
-
List item
Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene) (updated)
Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013,, , Revision: 21, Authorised, Last updated: 10/01/2022
-
List item
Human medicine European public assessment report (EPAR): Holoclar (updated)
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation; Corneal Diseases
Date of authorisation: 17/02/2015,, , , Revision: 8, Authorised, Last updated: 06/01/2022
-
List item
Human medicine European public assessment report (EPAR): Mepsevii (updated)
vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018,, , , Revision: 6, Authorised, Last updated: 06/01/2022
-
List item
Human medicine European public assessment report (EPAR): Zabdeno (updated)
Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,, , Revision: 2, Authorised, Last updated: 05/01/2022