For help on how to get the results you want, see our search tips.
1519 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Periodic safety update report single assessments Remove Periodic safety update report single assessments filter
Summaries of opinion Remove Summaries of opinion filter
Opinions on medicines for use outside EU Remove Opinions on medicines for use outside EU filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 20/07/2011,
, Revision: 19, Authorised, Last updated: 13/05/2022
-
List item
Human medicine European public assessment report (EPAR): Anagrelide Mylan (updated)
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,
, Revision: 5, Authorised, Last updated: 13/05/2022
-
List item
Human medicine European public assessment report (EPAR): Arsenic trioxide Mylan (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 01/04/2020,, Revision: 3, Authorised, Last updated: 13/05/2022
-
List item
Human medicine European public assessment report (EPAR): Ongentys (updated)
opicapone, Parkinson Disease
Date of authorisation: 24/06/2016, Revision: 8, Authorised, Last updated: 13/05/2022 -
List item
Human medicine European public assessment report (EPAR): Voncento (updated)
Human coagulation factor VIII, human von willebrand factor, Hemophilia A; von Willebrand Diseases
Date of authorisation: 12/08/2013, Revision: 15, Authorised, Last updated: 13/05/2022 -
List item
Human medicine European public assessment report (EPAR): Abraxane (updated)
paclitaxel, Breast Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 11/01/2008, Revision: 29, Authorised, Last updated: 13/05/2022 -
List item
Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic
Date of authorisation: 26/09/2017,
, Revision: 15, Authorised, Last updated: 13/05/2022
-
List item
Human medicine European public assessment report (EPAR): Replagal (updated)
agalsidase alfa, Fabry Disease
Date of authorisation: 03/08/2001, Revision: 25, Authorised, Last updated: 13/05/2022 -
List item
Human medicine European public assessment report (EPAR): Ilumetri (updated)
tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018,, Revision: 5, Authorised, Last updated: 13/05/2022
-
List item
Human medicine European public assessment report (EPAR): Zytiga (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,
, Revision: 24, Authorised, Last updated: 13/05/2022
-
List item
Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, , Revision: 33, Authorised, Last updated: 12/05/2022
-
List item
Human medicine European public assessment report (EPAR): Imraldi (updated)
adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017,, 
, Revision: 16, Authorised, Last updated: 12/05/2022
-
List item
Human medicine European public assessment report (EPAR): SomaKit TOC (updated)
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,, Revision: 11, Authorised, Last updated: 12/05/2022
-
List item
Human medicine European public assessment report (EPAR): Axumin (updated)
Fluciclovine (18F), Prostatic Neoplasms; Radionuclide Imaging
Date of authorisation: 21/05/2017, Revision: 15, Authorised, Last updated: 12/05/2022 -
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: 22, Authorised, Last updated: 12/05/2022
-
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: 25, Authorised, Last updated: 12/05/2022
-
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: 20, Authorised, Last updated: 12/05/2022
-
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: 19, Authorised, Last updated: 12/05/2022
-
List item
Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 2, Authorised, Last updated: 12/05/2022
-
List item
Human medicine European public assessment report (EPAR): Bevespi Aerosphere (updated)
glycopyrronium, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 18/12/2018, Revision: 4, Authorised, Last updated: 12/05/2022 -
List item
Human medicine European public assessment report (EPAR): Hexacima (updated)
hepatitis B surface antigen, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett), Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 25, Authorised, Last updated: 12/05/2022 -
List item
Human medicine European public assessment report (EPAR): ProQuad (updated)
virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella, Chickenpox; Rubella; Measles; Mumps; Immunization
Date of authorisation: 05/04/2006, Revision: 30, Authorised, Last updated: 12/05/2022 -
List item
Human medicine European public assessment report (EPAR): Hexyon (updated)
filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Diphtheria toxoid, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 26, Authorised, Last updated: 12/05/2022 -
List item
Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,, Revision: 13, Authorised, Last updated: 12/05/2022
-
List item
Human medicine European public assessment report (EPAR): Ozawade (updated)
pitolisant, Sleep Apnea, Obstructive
Date of authorisation: 01/09/2021, Revision: 2, Authorised, Last updated: 12/05/2022