For help on how to get the results you want, see our search tips.
294 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Orphan designations Remove Orphan designations filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
-
List item
Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, 
, Revision: 31, Authorised, Last updated: 26/01/2022
-
List item
Human medicine European public assessment report (EPAR): Obiltoxaximab SFL (updated)
Obiltoxaximab, Anthrax
Date of authorisation: 18/11/2020,
, , 
, Revision: 1, Authorised, Last updated: 26/01/2022
-
List item
Human medicine European public assessment report (EPAR): Harvoni (updated)
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, , Revision: 24, Authorised, Last updated: 25/01/2022
-
List item
Human medicine European public assessment report (EPAR): Verkazia (updated)
ciclosporin, Conjunctivitis; Keratitis
Date of authorisation: 06/07/2018,, , Revision: 6, Authorised, Last updated: 25/01/2022
-
List item
Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , 
, Revision: 12, Authorised, Last updated: 21/01/2022
-
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: 5, Authorised, Last updated: 20/01/2022
-
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: 16, Authorised, Last updated: 20/01/2022
-
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: 19, Authorised, Last updated: 20/01/2022
-
List item
Human medicine European public assessment report (EPAR): Voraxaze (updated)
glucarpidase, Metabolic Side Effects of Drugs and Substances
Date of authorisation: 11/01/2022,, , , Authorised, Last updated: 20/01/2022
-
List item
Human medicine European public assessment report (EPAR): Takhzyro (updated)
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 7, Authorised, Last updated: 19/01/2022
-
List item
Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,, , Revision: 1, Authorised, Last updated: 19/01/2022
-
List item
Human medicine European public assessment report (EPAR): Onpattro (updated)
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,, , , Revision: 9, Authorised, Last updated: 19/01/2022
-
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: 18, Authorised, Last updated: 18/01/2022
-
List item
Human medicine European public assessment report (EPAR): Epclusa (updated)
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, , Revision: 17, 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): Retsevmo (updated)
Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021,, , Revision: 2, Authorised, Last updated: 14/01/2022
-
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): 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): 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): 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): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Authorised, Last updated: 07/01/2022
-
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