For help on how to get the results you want, see our search tips.
1252 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Orphan designations Remove Orphan designations filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Categories
Human Remove Human filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Renagel (updated)
sevelamer, Renal Dialysis; Hyperphosphatemia
Date of authorisation: 28/01/2000, Revision: 34, Authorised, Last updated: 03/12/2021 -
List item
Human medicine European public assessment report (EPAR): Axumin (updated)
Fluciclovine (18F), Prostatic Neoplasms; Radionuclide Imaging
Date of authorisation: 21/05/2017,
, Revision: 13, Authorised, Last updated: 03/12/2021
-
List item
Human medicine European public assessment report (EPAR): Ultomiris (updated)
ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019,, Revision: 7, Authorised, Last updated: 03/12/2021
-
List item
Human medicine European public assessment report (EPAR): Atectura Breezhaler (updated)
indacaterol acetate, Mometasone furoate, Asthma
Date of authorisation: 30/05/2020, Revision: 3, Authorised, Last updated: 03/12/2021 -
List item
Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V. (updated)
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,
, Revision: 17, Authorised, Last updated: 03/12/2021
-
List item
Human medicine European public assessment report (EPAR): RoActemra (updated)
tocilizumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid
Date of authorisation: 15/01/2009, Revision: 35, Authorised, Last updated: 03/12/2021 -
List item
Human medicine European public assessment report (EPAR): Fareston (updated)
toremifene, Breast Neoplasms
Date of authorisation: 14/02/1996, Revision: 24, Authorised, Last updated: 03/12/2021 -
List item
Human medicine European public assessment report (EPAR): Aripiprazole Accord (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 12, Authorised, Last updated: 03/12/2021
-
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: 17, Authorised, Last updated: 03/12/2021
-
List item
Human medicine European public assessment report (EPAR): Rapamune (updated)
Sirolimus, Graft Rejection; Kidney Transplantation
Date of authorisation: 13/03/2001, Revision: 44, Authorised, Last updated: 03/12/2021 -
List item
Human medicine European public assessment report (EPAR): Incresync (updated)
alogliptin, pioglitazone, Diabetes Mellitus, Type 2
Date of authorisation: 19/09/2013, Revision: 12, Authorised, Last updated: 03/12/2021 -
List item
Human medicine European public assessment report (EPAR): Qtern (updated)
Saxagliptin, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Diabetes Mellitus; Nutritional and Metabolic Diseases; Metabolic Diseases; Glucose Metabolism Disorders
Date of authorisation: 15/07/2016, Revision: 8, Authorised, Last updated: 02/12/2021 -
List item
Human medicine European public assessment report (EPAR): Teysuno (updated)
tegafur, gimeracil, oteracil, Stomach Neoplasms
Date of authorisation: 14/03/2011,
, Revision: 19, Authorised, Last updated: 02/12/2021
-
List item
Human medicine European public assessment report (EPAR): Blitzima (updated)
rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, 
, Revision: 12, Authorised, Last updated: 02/12/2021
-
List item
Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,
, Revision: 23, Authorised, Last updated: 02/12/2021
-
List item
Human medicine European public assessment report (EPAR): Gencebok (updated)
Caffeine citrate, Apnea
Date of authorisation: 19/08/2020, Revision: 5, Authorised, Last updated: 02/12/2021 -
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: 24, Authorised, Last updated: 02/12/2021 -
List item
Human medicine European public assessment report (EPAR): Stivarga (updated)
regorafenib, Colorectal Neoplasms
Date of authorisation: 26/08/2013, Revision: 17, Authorised, Last updated: 02/12/2021 -
List item
Human medicine European public assessment report (EPAR): Iclusig (updated)
ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,, , 
, Revision: 22, Authorised, Last updated: 02/12/2021
-
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: 25, Authorised, Last updated: 02/12/2021 -
List item
Human medicine European public assessment report (EPAR): Renvela (updated)
sevelamer carbonate, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 09/06/2009, Revision: 23, Authorised, Last updated: 02/12/2021 -
List item
Human medicine European public assessment report (EPAR): Lynparza (updated)
Olaparib, Ovarian Neoplasms
Date of authorisation: 16/12/2014, Revision: 16, Authorised, Last updated: 02/12/2021 -
List item
Human medicine European public assessment report (EPAR): Cabometyx (updated)
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,, Revision: 13, Authorised, Last updated: 01/12/2021
-
List item
Human medicine European public assessment report (EPAR): Lantus (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 09/06/2000, Revision: 37, Authorised, Last updated: 01/12/2021 -
List item
Human medicine European public assessment report (EPAR): Inflectra (updated)
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 28, Authorised, Last updated: 01/12/2021