For help on how to get the results you want, see our search tips.
351 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
Categories
Human Remove Human filter
Medicine type
Additional monitoring Remove Additional monitoring filter
Conditional approval Remove Conditional approval filter
Biosimilar Remove Biosimilar filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Strensiq (updated)
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,
, 
, 
, Revision: 14, Authorised, Last updated: 25/03/2021
-
List item
Human medicine European public assessment report (EPAR): Lenvima (updated)
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, 
, Revision: 15, Authorised, Last updated: 25/03/2021
-
List item
Human medicine European public assessment report (EPAR): Lemtrada (updated)
alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013,
, , Revision: 11, Authorised, Last updated: 25/03/2021
-
List item
Human medicine European public assessment report (EPAR): Rizmoic (updated)
Naldemedine tosilate, Constipation
Date of authorisation: 18/02/2019,, Revision: 5, Authorised, Last updated: 24/03/2021
-
List item
Human medicine European public assessment report (EPAR): Giapreza (updated)
Angiotensin II acetate, Hypotension, Shock
Date of authorisation: 23/08/2019,, Revision: 1, Authorised, Last updated: 23/03/2021
-
List item
Human medicine European public assessment report (EPAR): Omnitrope (updated)
somatropin, Turner Syndrome, Prader-Willi Syndrome, Dwarfism, Pituitary
Date of authorisation: 12/04/2006,
, Revision: 17, Authorised, Last updated: 23/03/2021
-
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: 15, Authorised, Last updated: 23/03/2021
-
List item
Human medicine European public assessment report (EPAR): Nyvepria (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, , Revision: 1, Authorised, Last updated: 23/03/2021
-
List item
Human medicine European public assessment report (EPAR): Dectova (updated)
Zanamivir, Influenza, Human
Date of authorisation: 26/04/2019,, Revision: 3, Authorised, Last updated: 23/03/2021
-
List item
Human medicine European public assessment report (EPAR): Rekovelle (updated)
follitropin delta, Anovulation
Date of authorisation: 12/12/2016,, Revision: 2, Authorised, Last updated: 22/03/2021
-
List item
Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria) (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014,, Revision: 11, Authorised, Last updated: 22/03/2021
-
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,, , Authorised, Last updated: 19/03/2021
-
List item
Human medicine European public assessment report (EPAR): Givlaari (updated)
Givosiran, Porphyrias, Hepatic
Date of authorisation: 02/03/2020,, , Revision: 1, Authorised, Last updated: 18/03/2021
-
List item
Human medicine European public assessment report (EPAR): Cerdelga (updated)
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,, , Revision: 12, Authorised, Last updated: 18/03/2021
-
List item
Human medicine European public assessment report (EPAR): Daxas (updated)
roflumilast, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 05/07/2010,, Revision: 16, Authorised, Last updated: 18/03/2021
-
List item
Human medicine European public assessment report (EPAR): Trumenba (updated)
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B, Meningitis, Meningococcal
Date of authorisation: 24/05/2017,, Revision: 9, Authorised, Last updated: 17/03/2021
-
List item
Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 2, Authorised, Last updated: 17/03/2021
-
List item
Human medicine European public assessment report (EPAR): Nustendi (updated)
Bempedoic acid, Ezetimibe, Hypercholesterolemia, Dyslipidemias
Date of authorisation: 27/03/2020,, Revision: 3, Authorised, Last updated: 17/03/2021
-
List item
Human medicine European public assessment report (EPAR): Blenrep (updated)
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Revision: 2, Authorised, Last updated: 17/03/2021
-
List item
Human medicine European public assessment report (EPAR): Naglazyme (updated)
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,, , Revision: 18, Authorised, Last updated: 17/03/2021
-
List item
Human medicine European public assessment report (EPAR): Alprolix (updated)
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,, , Revision: 7, Authorised, Last updated: 17/03/2021
-
List item
Human medicine European public assessment report (EPAR): Laventair Ellipta (previously Laventair)
umeclidinium bromide, vilanterol, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 08/05/2014,, Revision: 15, Authorised, Last updated: 12/03/2021
-
List item
Human medicine European public assessment report (EPAR): Viekirax
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, , Revision: 22, Authorised, Last updated: 12/03/2021
-
List item
Human medicine European public assessment report (EPAR): Temybric Ellipta
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 12/06/2019,, Revision: 3, Authorised, Last updated: 12/03/2021
-
List item
Human medicine European public assessment report (EPAR): Anoro Ellipta (previously Anoro)
umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 08/05/2014,, Revision: 16, Authorised, Last updated: 11/03/2021