For help on how to get the results you want, see our search tips.
84 results
Medicine
Shortages Remove Shortages filter
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Summaries of opinion Remove Summaries of opinion filter
Withdrawn applications Remove Withdrawn applications filter
-
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: 7, Authorised, Last updated: 09/04/2021
-
List item
Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , 
, Revision: 3, Authorised, Last updated: 09/04/2021
-
List item
Human medicine European public assessment report (EPAR): Rubraca (updated)
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,, , Revision: 6, Authorised, Last updated: 09/04/2021
-
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: 3, Authorised, Last updated: 08/04/2021
-
List item
Human medicine European public assessment report (EPAR): Brineura (updated)
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,, , , 
, Revision: 5, Authorised, Last updated: 08/04/2021
-
List item
Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, , Revision: 6, Authorised, Last updated: 07/04/2021
-
List item
Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, , Revision: 13, Authorised, Last updated: 07/04/2021
-
List item
Human medicine European public assessment report (EPAR): Exviera (updated)
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, , Revision: 19, Authorised, Last updated: 06/04/2021
-
List item
Human medicine European public assessment report (EPAR): Epclusa (updated)
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, , Revision: 14, Authorised, Last updated: 31/03/2021
-
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: 4, Authorised, Last updated: 30/03/2021
-
List item
Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) 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: 06/01/2021,, , Revision: 1, Authorised, Last updated: 30/03/2021
-
List item
Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , , Revision: 21, Authorised, Last updated: 29/03/2021
-
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
Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N2 (updated)
inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), Chicken
Date of authorisation: 01/09/2006,, Revision: 8, Authorised, Last updated: 25/03/2021
-
List item
Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 21, 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): 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): 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): Viekirax (updated)
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): Ninlaro
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 9, Authorised, Last updated: 03/03/2021
-
List item
Human medicine European public assessment report (EPAR): Maviret
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, , Revision: 11, Authorised, Last updated: 03/03/2021
-
List item
Human medicine European public assessment report (EPAR): Ondexxya
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, , Revision: 8, Authorised, Last updated: 01/03/2021
-
List item
Human medicine European public assessment report (EPAR): Vpriv
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, , Revision: 14, Authorised, Last updated: 26/02/2021
-
List item
Human medicine European public assessment report (EPAR): Prepandrix
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 14/05/2008,, Revision: 13, Withdrawn, Last updated: 23/02/2021
-
List item
Human medicine European public assessment report (EPAR): Spinraza
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, , , Revision: 11, Authorised, Last updated: 22/02/2021