For help on how to get the results you want, see our search tips.
335 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
Medicine type
Conditional approval Remove Conditional approval filter
Generic Remove Generic filter
Accelerated assessment Remove Accelerated assessment filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Ambrisentan Mylan (updated)
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,
, Revision: 3, Authorised, Last updated: 29/06/2022
-
List item
Human medicine European public assessment report (EPAR): Spikevax (previously 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: 24, Authorised, Last updated: 29/06/2022
-
List item
Human medicine European public assessment report (EPAR): Prasugrel Mylan (updated)
prasugrel besilate, Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable
Date of authorisation: 15/05/2018,, Revision: 8, Authorised, Last updated: 28/06/2022
-
List item
Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,, Revision: 15, Authorised, Last updated: 28/06/2022
-
List item
Human medicine European public assessment report (EPAR): Rozlytrek (updated)
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,, , Revision: 4, Authorised, Last updated: 27/06/2022
-
List item
Human medicine European public assessment report (EPAR): Mycophenolate mofetil Teva (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 25, Authorised, Last updated: 24/06/2022
-
List item
Human medicine European public assessment report (EPAR): Azacitidine Mylan (updated)
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 4, Authorised, Last updated: 24/06/2022
-
List item
Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 17, Authorised, Last updated: 24/06/2022
-
List item
Human medicine European public assessment report (EPAR): Sapropterin Dipharma (updated)
Sapropterin dihydrochloride, Phenylketonurias
Date of authorisation: 16/02/2022,, Revision: 1, Authorised, Last updated: 24/06/2022
-
List item
Human medicine European public assessment report (EPAR): Desloratadine ratiopharm (updated)
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,, Revision: 12, Authorised, Last updated: 24/06/2022
-
List item
Human medicine European public assessment report (EPAR): Zoledronic acid Mylan (updated)
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 13, Authorised, Last updated: 24/06/2022
-
List item
Human medicine European public assessment report (EPAR): Sildenafil ratiopharm (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 23/12/2009,, Revision: 19, Authorised, Last updated: 24/06/2022
-
List item
Human medicine European public assessment report (EPAR): Imatinib Accord (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013,, Revision: 23, Authorised, Last updated: 23/06/2022
-
List item
Human medicine European public assessment report (EPAR): Myfenax (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 26, Authorised, Last updated: 23/06/2022
-
List item
Human medicine European public assessment report (EPAR): Lunsumio (updated)
mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022,, 
, , Authorised, Last updated: 23/06/2022
-
List item
Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,
, , Revision: 2, Authorised, Last updated: 22/06/2022
-
List item
Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan (updated)
sitagliptin hydrochloride monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022,, Revision: 1, Authorised, Last updated: 21/06/2022
-
List item
Human medicine European public assessment report (EPAR): Kanuma (updated)
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,, , , Revision: 8, Authorised, Last updated: 21/06/2022
-
List item
Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, Revision: 16, Authorised, Last updated: 20/06/2022
-
List item
Human medicine European public assessment report (EPAR): Carvykti (updated)
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Dimethyl fumarate Polpharma (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 01, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, , Revision: 12, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Gefitinib Mylan (updated)
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,, Revision: 5, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, Revision: 17, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Jcovden (previously 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: 20, Authorised, Last updated: 17/06/2022