For help on how to get the results you want, see our search tips.
570 results
Categories
Human Remove Human filter
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Medicine type
Generic Remove Generic filter
Additional monitoring Remove Additional monitoring filter
Exceptional circumstances Remove Exceptional circumstances filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Pregabalin Sandoz (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,
, Revision: 13, Authorised, Last updated: 01/07/2022
-
List item
Human medicine European public assessment report (EPAR): Levetiracetam Actavis (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 18, Authorised, Last updated: 01/07/2022
-
List item
Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 12, Authorised, Last updated: 01/07/2022
-
List item
Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva (updated)
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,
, Authorised, Last updated: 01/07/2022
-
List item
Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan) (updated)
clopidogrel hydrochloride, Peripheral Vascular Diseases; Stroke; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 21/09/2009,, Revision: 20, Authorised, Last updated: 01/07/2022
-
List item
Human medicine European public assessment report (EPAR): Levetiracetam Actavis Group (updated)
levetiracetam, Epilepsy
Date of authorisation: 04/12/2011,, Revision: 16, Authorised, Last updated: 01/07/2022
-
List item
Human medicine European public assessment report (EPAR): Caprelsa (updated)
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, 
, Revision: 22, Authorised, Last updated: 30/06/2022
-
List item
Human medicine European public assessment report (EPAR): Abiraterone Mylan (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,, Revision: 2, Authorised, Last updated: 30/06/2022
-
List item
Human medicine European public assessment report (EPAR): Tadalafil Mylan (updated)
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 14, Authorised, Last updated: 30/06/2022
-
List item
Human medicine European public assessment report (EPAR): Memantine ratiopharm (updated)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 12/06/2013,, Revision: 8, Authorised, Last updated: 30/06/2022
-
List item
Human medicine European public assessment report (EPAR): HyQvia (updated)
Human normal immunoglobulin, Immunologic Deficiency Syndromes
Date of authorisation: 16/05/2013,, Revision: 18, Authorised, Last updated: 30/06/2022
-
List item
Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, 
, , Revision: 13, Authorised, Last updated: 30/06/2022
-
List item
Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015,, Revision: 46, Authorised, Last updated: 29/06/2022
-
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): Vocabria (updated)
Cabotegavir sodium, Cabotegravir, HIV Infections
Date of authorisation: 17/12/2020,, Revision: 5, Authorised, Last updated: 27/06/2022
-
List item
Human medicine European public assessment report (EPAR): Ozempic (updated)
semaglutide, Diabetes Mellitus
Date of authorisation: 08/02/2018,, Revision: 8, 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