8469 results
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Human medicine European public assessment report (EPAR): Fasenra (updated)
benralizumab, Asthma
Date of authorisation: 08/01/2018, Additional monitoring, Revision: 2, Authorised -
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Human medicine European public assessment report (EPAR): Telzir (updated)
fosamprenavir, HIV Infections
Date of authorisation: 12/07/2004, Revision: 39, Authorised -
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Human medicine European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif) (updated)
human normal immunoglobulin, Mucocutaneous Lymph Node Syndrome Guillain-Barre Syndrome Bone Marrow Transplantation Purpura, Thrombocytopenic, Idiopathic Immunologic Deficiency Syndromes
Date of authorisation: 23/07/2007, Revision: 15, Authorised -
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Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic
Date of authorisation: 27/09/2017, Additional monitoring, Revision: 2, Authorised -
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Human medicine European public assessment report (EPAR): Praxbind (updated)
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015, Additional monitoring, Revision: 5, Authorised -
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Veterinary medicine European public assessment report (EPAR): Cepedex (updated)
dexmedetomidine, Cats Dogs
Date of authorisation: 13/12/2016, Revision: 2, Authorised -
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Human medicine European public assessment report (EPAR): Kaletra (updated)
lopinavir / ritonavir, HIV Infections
Date of authorisation: 20/03/2001, Revision: 49, Authorised -
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Human medicine European public assessment report (EPAR): Imraldi (updated)
adalimumab, Hidradenitis Suppurativa Psoriasis Crohn Disease Uveitis Arthritis, Rheumatoid Arthritis Colitis, Ulcerative Spondylitis, Ankylosing Arthritis, Psoriatic
Date of authorisation: 24/08/2017, Additional monitoring, Biosimilar, Revision: 6, Authorised -
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015, Additional monitoring, Revision: 3, Authorised -
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Veterinary medicine European public assessment report (EPAR): MS-H Vaccine (updated)
Mycoplasma synoviae (live), Chicken
Date of authorisation: 14/06/2011, Revision: 4, Authorised -
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Human medicine European public assessment report (EPAR): Abilify (updated)
aripiprazole, Schizophrenia Bipolar Disorder
Date of authorisation: 04/06/2004, Revision: 42, Authorised -
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Human medicine European public assessment report (EPAR): Steglatro (updated)
ertugliflozin, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2018, Additional monitoring, Revision: 2, Authorised -
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Human medicine European public assessment report (EPAR): Viread (updated)
tenofovir disoproxil, Hepatitis B, Chronic HIV Infections
Date of authorisation: 05/02/2002, Revision: 49, Authorised -
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Human medicine European public assessment report (EPAR): Lumigan (updated)
bimatoprost, Glaucoma, Open-Angle Ocular Hypertension
Date of authorisation: 08/03/2002, Revision: 29, Authorised -
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Human medicine European public assessment report (EPAR): Incruse Ellipta (previously Incruse) (updated)
umeclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 28/04/2014, Additional monitoring, Revision: 9, Authorised -
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Human medicine European public assessment report (EPAR): Xigduo (updated)
dapagliflozin / metformin, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 10, Authorised -
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Human medicine European public assessment report (EPAR): Orkambi (updated)
lumacaftor / ivacaftor, Cystic Fibrosis
Date of authorisation: 19/11/2015, Additional monitoring, Revision: 12, Authorised -
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Human medicine European public assessment report (EPAR): Sovaldi (updated)
sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014, Additional monitoring, Revision: 14, Authorised -
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Human medicine European public assessment report (EPAR): Anoro Ellipta (previously Anoro) (updated)
umeclidinium bromide / vilanterol, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 08/05/2014, Additional monitoring, Revision: 8, Authorised -
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Human medicine European public assessment report (EPAR): Prasugrel Mylan (updated)
prasugrel, Myocardial Infarction Acute Coronary Syndrome Angina, Unstable
Date of authorisation: 16/05/2018, Generic, Revision: 2, Authorised -
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Human medicine European public assessment report (EPAR): Spherox (updated)
spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases
Date of authorisation: 10/07/2017, Additional monitoring, Revision: 2, Authorised -
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Human medicine European public assessment report (EPAR): Zavesca (updated)
miglustat, Gaucher Disease Niemann-Pick Diseases
Date of authorisation: 20/11/2002, Revision: 28, Authorised -
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Veterinary medicine European public assessment report (EPAR): Broadline (updated)
eprinomectin, fipronil, praziquantel, (S)-methoprene, Cats
Date of authorisation: 04/12/2013, Revision: 6, Authorised -
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Human medicine European public assessment report (EPAR): Aclasta (updated)
zoledronic acid, Osteoporosis Osteitis Deformans Osteoporosis, Postmenopausal
Date of authorisation: 15/04/2005, Revision: 24, Authorised -
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Veterinary medicine European public assessment report (EPAR): Equilis West Nile (updated)
inactivated chimaeric flavivirus strain YF-WN, Horses
Date of authorisation: 06/06/2013, Revision: 2, Authorised