607 results
Medicine type
Orphan medicine Remove Orphan medicine filter
Accelerated assessment Remove Accelerated assessment filter
Generic Remove Generic filter
Additional monitoring Remove Additional monitoring filter
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka (updated)
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 09/12/2016,, Revision: 9, Authorised, Last updated: 09/04/2021
-
List item
Human medicine European public assessment report (EPAR): Zoledronic acid Mylan (updated)
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 11, Authorised, Last updated: 09/04/2021
-
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): Opsumit (updated)
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,, Revision: 17, 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): Ogivri (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 12/12/2018,,
, Revision: 6, 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): Olanzapine Teva (updated)
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 12/12/2007,, Revision: 28, 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): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (updated)
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 6, Authorised, Last updated: 08/04/2021
-
List item
Human medicine European public assessment report (EPAR): Doptelet (updated)
avatrombopag maleate, Thrombocytopenia
Date of authorisation: 20/06/2019,, Revision: 4, Authorised, Last updated: 07/04/2021
-
List item
Human medicine European public assessment report (EPAR): Kymriah (updated)
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,,
, Revision: 4, Authorised, Last updated: 07/04/2021
-
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): Senshio (updated)
ospemifene, Postmenopause
Date of authorisation: 14/01/2015,, Revision: 11, Authorised, Last updated: 07/04/2021
-
List item
Human medicine European public assessment report (EPAR): Vaxchora (updated)
vibrio cholerae, strain cvd 103-hgr, live, Cholera
Date of authorisation: 01/04/2020,, Revision: 2, 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): Pemetrexed Hospira (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 19/11/2015,, Revision: 11, Authorised, Last updated: 06/04/2021
-
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): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 10, Authorised, Last updated: 06/04/2021
-
List item
Human medicine European public assessment report (EPAR): Aybintio (updated)
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020,,
, Revision: 2, Authorised, Last updated: 06/04/2021
-
List item
Human medicine European public assessment report (EPAR): Ivozall (updated)
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/11/2019,, Revision: 2, Authorised, Last updated: 31/03/2021
-
List item
Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck
Date of authorisation: 17/07/2015,, Revision: 32, Authorised, Last updated: 31/03/2021
-
List item
Human medicine European public assessment report (EPAR): Levetiracetam Teva (updated)
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 17, Authorised, Last updated: 31/03/2021
-
List item
Human medicine European public assessment report (EPAR): Matever (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 22, Authorised, Last updated: 31/03/2021