8281 results
-
List item
Human medicine European public assessment report (EPAR): Xoterna Breezhaler (updated)
indacaterol / glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 18/09/2013, Additional monitoring, Revision: 11, Authorised -
List item
Human medicine European public assessment report (EPAR): Carmustine Obvius (updated)
carmustine, Hodgkin Disease Multiple Myeloma Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018, Generic, Revision: 1, Authorised -
List item
Human medicine European public assessment report (EPAR): Privigen (updated)
human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic Bone Marrow Transplantation Immunologic Deficiency Syndromes Guillain-Barre Syndrome Mucocutaneous Lymph Node Syndrome
Date of authorisation: 24/04/2008, Revision: 22, Authorised -
List item
Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat, Fabry Disease
Date of authorisation: 25/05/2016, Additional monitoring, Revision: 7, Authorised -
List item
Human medicine European public assessment report (EPAR): Champix (updated)
varenicline, Tobacco Use Cessation
Date of authorisation: 25/09/2006, Revision: 33, Authorised -
List item
Human medicine European public assessment report (EPAR): Wilzin (updated)
zinc, Hepatolenticular Degeneration
Date of authorisation: 12/10/2004, Revision: 9, Authorised -
List item
Human medicine European public assessment report (EPAR): Cyltezo (updated)
adalimumab, Hidradenitis Suppurativa Arthritis, Psoriatic Psoriasis Crohn Disease Arthritis, Juvenile Rheumatoid Uveitis Arthritis, Rheumatoid Colitis, Ulcerative Spondylitis, Ankylosing
Date of authorisation: 10/11/2017, Additional monitoring, Biosimilar, Revision: 2, Authorised -
List item
Human medicine European public assessment report (EPAR): Zessly (updated)
infliximab, Arthritis, Psoriatic Psoriasis Crohn Disease Arthritis, Rheumatoid Colitis, Ulcerative Spondylitis, Ankylosing
Date of authorisation: 18/05/2018, Additional monitoring, Biosimilar, Revision: 1, Authorised -
List item
Human medicine European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover) (updated)
clopidogrel / acetylsalicylic acid, Acute Coronary Syndrome Myocardial Infarction
Date of authorisation: 14/03/2010, Revision: 21, Authorised -
List item
Human medicine European public assessment report (EPAR): Volibris (updated)
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/04/2008, Revision: 18, Authorised -
List item
Human medicine European public assessment report (EPAR): Mozobil (updated)
plerixafor, Multiple Myeloma Hematopoietic Stem Cell Transplantation Lymphoma
Date of authorisation: 30/07/2009, Revision: 15, Authorised -
List item
Human medicine European public assessment report (EPAR): Galvus (updated)
vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 25/09/2007, Revision: 16, Authorised -
List item
Human medicine European public assessment report (EPAR): Jalra (updated)
vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 18/11/2008, Revision: 16, Authorised -
List item
Human medicine European public assessment report (EPAR): Xiliarx (updated)
vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 19/11/2008, Revision: 16, Authorised -
List item
Human medicine European public assessment report (EPAR): Grastofil (updated)
filgrastim, Neutropenia
Date of authorisation: 17/10/2013, Additional monitoring, Biosimilar, Revision: 10, Authorised -
List item
Human medicine European public assessment report (EPAR): Caelyx (updated)
doxorubicin, Sarcoma, Kaposi Multiple Myeloma Ovarian Neoplasms Breast Neoplasms
Date of authorisation: 20/06/1996, Revision: 29, Authorised -
List item
Human medicine European public assessment report (EPAR): Moventig (updated)
naloxegol, Constipation Opioid-Related Disorders
Date of authorisation: 07/12/2014, Additional monitoring, Revision: 7, Authorised -
List item
Veterinary medicine European public assessment report (EPAR): Cerenia (updated)
maropitant, Dogs Cats
Date of authorisation: 28/09/2006, Revision: 19, Authorised -
List item
Human medicine European public assessment report (EPAR): Samsca (updated)
tolvaptan, Inappropriate ADH Syndrome
Date of authorisation: 02/08/2009, Revision: 11, Authorised -
List item
Human medicine European public assessment report (EPAR): Accofil (updated)
filgrastim, Neutropenia
Date of authorisation: 17/09/2014, Additional monitoring, Biosimilar, Revision: 8, Authorised -
List item
Human medicine European public assessment report (EPAR): Vfend (updated)
voriconazole, Candidiasis Mycoses Aspergillosis
Date of authorisation: 19/03/2002, Revision: 43, Authorised -
List item
Veterinary medicine European public assessment report (EPAR): Virbagen Omega (updated)
interferon (omega), Dogs Cats
Date of authorisation: 05/11/2001, Revision: 11, Authorised -
List item
Human medicine European public assessment report (EPAR): Pregabalin Mylan (updated)
pregabalin, Anxiety Disorders Epilepsy
Date of authorisation: 24/06/2015, Generic, Revision: 6, Authorised -
List item
Human medicine European public assessment report (EPAR): Bortezomib Sun (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016, Generic, Revision: 4, Authorised -
List item
Veterinary medicine European public assessment report (EPAR): Naxcel (updated)
ceftiofur, Pigs Cattle
Date of authorisation: 19/05/2005, Revision: 14, Authorised