For help on how to get the results you want, see our search tips.
313 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Referrals Remove Referrals filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Conditional approval Remove Conditional approval filter
Generic Remove Generic filter
Exceptional circumstances Remove Exceptional circumstances filter
Authorisation status
Authorised Remove Authorised filter
Categories
Human Remove Human filter
-
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): Emtricitabine/Tenofovir disoproxil Krka d.d. (updated)
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017,, Revision: 7, Authorised, Last updated: 22/02/2021
-
List item
Human medicine European public assessment report (EPAR): Levetiracetam ratiopharm (updated)
levetiracetam, Epilepsy
Date of authorisation: 26/08/2011,, Revision: 11, Authorised, Last updated: 22/02/2021
-
List item
Human medicine European public assessment report (EPAR): Spinraza (updated)
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,
, 
, 
, Revision: 11, Authorised, Last updated: 22/02/2021
-
List item
Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (updated)
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 6, Authorised, Last updated: 22/02/2021
-
List item
Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , 
, Revision: 20, Authorised, Last updated: 22/02/2021
-
List item
Human medicine European public assessment report (EPAR): Palonosetron Accord (updated)
Palonosetron, Vomiting, Nausea, Cancer
Date of authorisation: 26/05/2016,, Revision: 4, Authorised, Last updated: 18/02/2021
-
List item
Human medicine European public assessment report (EPAR): Crysvita (updated)
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 7, Authorised, Last updated: 18/02/2021
-
List item
Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Apotex) (updated)
clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 20, Authorised, Last updated: 17/02/2021
-
List item
Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 5, Authorised, Last updated: 17/02/2021
-
List item
Human medicine European public assessment report (EPAR): Darunavir Mylan (updated)
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 8, Authorised, Last updated: 16/02/2021
-
List item
Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 20, Authorised, Last updated: 16/02/2021
-
List item
Human medicine European public assessment report (EPAR): Mysildecard (updated)
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,, Revision: 3, Authorised, Last updated: 15/02/2021
-
List item
Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva (updated)
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,, Revision: 12, Authorised, Last updated: 11/02/2021
-
List item
Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan (updated)
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,, Revision: 12, Authorised, Last updated: 11/02/2021
-
List item
Human medicine European public assessment report (EPAR): Levetiracetam Actavis Group (updated)
levetiracetam, Epilepsy
Date of authorisation: 04/12/2011,, Revision: 14, Authorised, Last updated: 10/02/2021
-
List item
Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH (updated)
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 19/06/2015,, Revision: 7, Authorised, Last updated: 10/02/2021
-
List item
Human medicine European public assessment report (EPAR): Duloxetine Zentiva (updated)
duloxetine, Anxiety Disorders, Depressive Disorder, Major, Neuralgia, Diabetes Mellitus
Date of authorisation: 20/08/2015,, Revision: 8, Authorised, Last updated: 10/02/2021
-
List item
Human medicine European public assessment report (EPAR): Levetiracetam Accord (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 12, Authorised, Last updated: 10/02/2021
-
List item
Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 10, Authorised, Last updated: 10/02/2021
-
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: 1, Authorised, Last updated: 09/02/2021
-
List item
Human medicine European public assessment report (EPAR): Praxbind (updated)
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,, Revision: 9, Authorised, Last updated: 08/02/2021
-
List item
Human medicine European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva (updated)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 26/11/2009,, Revision: 18, Authorised, Last updated: 05/02/2021
-
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,, , Authorised, Last updated: 05/02/2021