For help on how to get the results you want, see our search tips.
810 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Orphan designations Remove Orphan designations filter
Referrals Remove Referrals filter
Withdrawn applications Remove Withdrawn applications filter
Categories
Human Remove Human filter
-
List item
Human medicine European public assessment report (EPAR): Bortezomib Sun (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,
, Revision: 10, Authorised, Last updated: 01/03/2021
-
List item
Human medicine European public assessment report (EPAR): Daptomycin Hospira (updated)
daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial
Date of authorisation: 22/03/2017,, Revision: 10, Authorised, Last updated: 01/03/2021
-
List item
Human medicine European public assessment report (EPAR): Flixabi (updated)
infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis
Date of authorisation: 26/05/2016,
, 
, Revision: 16, Authorised, Last updated: 01/03/2021
-
List item
Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 08/02/2018,, , Revision: 11, Authorised, Last updated: 01/03/2021
-
List item
Human medicine European public assessment report (EPAR): Pioglitazone Teva (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,, Revision: 11, Authorised, Last updated: 01/03/2021
-
List item
Human medicine European public assessment report (EPAR): Braftovi (updated)
Encorafenib, Melanoma, Colorectal Neoplasms
Date of authorisation: 19/09/2018,, Revision: 5, Authorised, Last updated: 01/03/2021
-
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: 8, Authorised, Last updated: 01/03/2021
-
List item
Human medicine European public assessment report (EPAR): Glivec (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001,, Revision: 40, Authorised, Last updated: 01/03/2021
-
List item
Human medicine European public assessment report (EPAR): Praluent (updated)
Alirocumab, Dyslipidemias
Date of authorisation: 23/09/2015,, Revision: 16, Authorised, Last updated: 01/03/2021
-
List item
Human medicine European public assessment report (EPAR): Pioglitazone Accord (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2012,, Revision: 6, Authorised, Last updated: 26/02/2021
-
List item
Human medicine European public assessment report (EPAR): Ilumetri (updated)
tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018,, Revision: 3, Authorised, Last updated: 26/02/2021
-
List item
Human medicine European public assessment report (EPAR): Vpriv (updated)
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): Lamivudine Teva (updated)
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 10, Authorised, Last updated: 26/02/2021
-
List item
Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)
clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009,, Revision: 16, Authorised, Last updated: 26/02/2021
-
List item
Human medicine European public assessment report (EPAR): Taltz (updated)
ixekizumab, Psoriasis
Date of authorisation: 25/04/2016,, Revision: 12, Authorised, Last updated: 26/02/2021
-
List item
Human medicine European public assessment report (EPAR): Myfenax (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 23, Authorised, Last updated: 26/02/2021
-
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: 3, Authorised, Last updated: 25/02/2021
-
List item
Human medicine European public assessment report (EPAR): Ervebo (updated)
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019,, Revision: 4, Authorised, Last updated: 25/02/2021
-
List item
Human medicine European public assessment report (EPAR): Dectova (updated)
Zanamivir, Influenza, Human
Date of authorisation: 26/04/2019,, Revision: 2, Authorised, Last updated: 25/02/2021
-
List item
Human medicine European public assessment report (EPAR): Entecavir Mylan (updated)
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 3, Authorised, Last updated: 25/02/2021
-
List item
Human medicine European public assessment report (EPAR): Truberzi (updated)
eluxadoline, Irritable Bowel Syndrome, Diarrhea
Date of authorisation: 19/09/2016,, Revision: 6, Withdrawn, Last updated: 25/02/2021
-
List item
Human medicine European public assessment report (EPAR): Pregabalin Accord (updated)
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 28/08/2015,, Revision: 9, Authorised, Last updated: 24/02/2021
-
List item
Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 14, Authorised, Last updated: 24/02/2021
-
List item
Human medicine European public assessment report (EPAR): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, , Revision: 17, Authorised, Last updated: 24/02/2021
-
List item
Human medicine European public assessment report (EPAR): Neparvis (updated)
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,, Revision: 11, Authorised, Last updated: 24/02/2021