For help on how to get the results you want, see our search tips.
30 results
Keyword Remove keyword
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Orphan designations Remove Orphan designations filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Categories
Human Remove Human filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 10/10/2009,
, Revision: 10, Authorised, Last updated: 06/11/2019
-
List item
Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,
, , Revision: 24, Authorised, Last updated: 04/12/2020
-
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): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,, , Revision: 12, Authorised, Last updated: 01/08/2018
-
List item
Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous, Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,, , , Revision: 3, Authorised, Last updated: 24/11/2017
-
List item
Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , , Revision: 13, Authorised, Last updated: 28/01/2021
-
List item
Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,, , Revision: 20, Authorised, Last updated: 24/06/2020
-
List item
Human medicine European public assessment report (EPAR): Elzonris
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , , Authorised, Last updated: 25/01/2021
-
List item
Human medicine European public assessment report (EPAR): Evoltra
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006,, , Revision: 29, Authorised, Last updated: 30/11/2020
-
List item
Human medicine European public assessment report (EPAR): Firdapse (previously Zenas)
amifampridine, Lambert-Eaton Myasthenic Syndrome
Date of authorisation: 23/12/2009,, , Revision: 20, Authorised, Last updated: 26/11/2020
-
List item
Human medicine European public assessment report (EPAR): Foclivia
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009,, Revision: 11, Authorised, Last updated: 10/03/2021
-
List item
Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine
Date of authorisation: 31/07/2013,, , Revision: 18, Authorised, Last updated: 14/12/2020
-
List item
Human medicine European public assessment report (EPAR): Increlex
Mecasermin, Laron Syndrome
Date of authorisation: 02/08/2007,, , Revision: 21, Authorised, Last updated: 20/04/2020
-
List item
Human medicine European public assessment report (EPAR): Lamzede
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,, , , Revision: 3, Authorised, Last updated: 24/11/2020
-
List item
Human medicine European public assessment report (EPAR): Lojuxta
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,, , Revision: 13, Authorised, Last updated: 27/01/2021
-
List item
Human medicine European public assessment report (EPAR): Mepsevii
vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018,, , , Revision: 5, Authorised, Last updated: 13/10/2020
-
List item
Human medicine European public assessment report (EPAR): Mvabea
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,, , Authorised, Last updated: 24/11/2020
-
List item
Human medicine European public assessment report (EPAR): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,, , , Revision: 5, Authorised, Last updated: 10/12/2020
-
List item
Human medicine European public assessment report (EPAR): Naglazyme
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,, , Revision: 18, Authorised, Last updated: 17/03/2021
-
List item
Human medicine European public assessment report (EPAR): Obiltoxaximab SFL
Obiltoxaximab, Anthrax
Date of authorisation: 18/11/2020,, , , Authorised, Last updated: 27/11/2020
-
List item
Human medicine European public assessment report (EPAR): Obizur
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,, , Revision: 6, Authorised, Last updated: 27/11/2020
-
List item
Human medicine European public assessment report (EPAR): Orphacol
cholic acid, Digestive System Diseases, Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , , Revision: 9, Authorised, Last updated: 11/08/2020
-
List item
Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 16/10/2009,, Revision: 6, Authorised, Last updated: 18/01/2019
-
List item
Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,, , , Revision: 8, Authorised, Last updated: 28/01/2020
-
List item
Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,, , , Revision: 6, Authorised, Last updated: 31/08/2020