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Human medicine European public assessment report (EPAR): Pregabalin Sandoz (updated)
pregabalin, Anxiety Disorders, Neuralgia, Epilepsy
Date of authorisation: 19/06/2015,
, Revision: 6, Authorised, Last updated: 10/05/2021
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Human medicine European public assessment report (EPAR): Kyprolis (updated)
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,
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, Revision: 19, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): 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,
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, Revision: 2, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 6, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Volibris (updated)
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/04/2008, Revision: 21, Authorised, Last updated: 07/05/2021 -
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Human medicine European public assessment report (EPAR): 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: 2, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Fycompa (updated)
perampanel, Epilepsies, Partial
Date of authorisation: 23/07/2012, Revision: 21, Authorised, Last updated: 07/05/2021 -
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Human medicine European public assessment report (EPAR): Ketoconazole HRA (updated)
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 10, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Vaborem (updated)
meropenem trihydrate, vaborbactam, Urinary Tract Infections, Bacteremia, Bacterial Infections, Respiratory Tract Infections, Pneumonia, Pneumonia, Ventilator-Associated
Date of authorisation: 20/11/2018,, Revision: 4, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Trizivir (updated)
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 37, Authorised, Last updated: 07/05/2021 -
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Human medicine European public assessment report (EPAR): Myocet liposomal (previously Myocet) (updated)
doxorubicin hydrochloride, Breast Neoplasms
Date of authorisation: 13/07/2000, Revision: 23, Authorised, Last updated: 07/05/2021 -
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Human medicine European public assessment report (EPAR): Opdivo (updated)
nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell, Urologic Neoplasms
Date of authorisation: 19/06/2015, Revision: 38, Authorised, Last updated: 07/05/2021 -
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Human medicine European public assessment report (EPAR): Perjeta (updated)
pertuzumab, Breast Neoplasms
Date of authorisation: 04/03/2013, Revision: 20, Authorised, Last updated: 07/05/2021 -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 10, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Seebri Breezhaler (updated)
glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 28/09/2012, Revision: 11, Authorised, Last updated: 07/05/2021 -
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 05/07/2018,, , , Revision: 7, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Jinarc (updated)
Tolvaptan, Polycystic Kidney, Autosomal Dominant
Date of authorisation: 27/05/2015,, Revision: 16, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Latuda (updated)
lurasidone, Schizophrenia
Date of authorisation: 21/03/2014, Revision: 23, Authorised, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Aldara (updated)
imiquimod, Condylomata Acuminata, Keratosis, Keratosis, Actinic, Carcinoma, Basal Cell
Date of authorisation: 18/09/1998, Revision: 28, Authorised, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Humira (updated)
adalimumab, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Uveitis, Colitis, Ulcerative, Psoriasis, Arthritis, Psoriatic, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 08/09/2003, Revision: 82, Authorised, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 3, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Aflunov (updated)
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 28/11/2010, Revision: 13, Authorised, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Flixabi (updated)
infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis
Date of authorisation: 26/05/2016,, 
, Revision: 17, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Jylamvo (updated)
Methotrexate, Arthritis, Psoriatic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Psoriasis, Arthritis, Rheumatoid, Arthritis
Date of authorisation: 29/03/2017, Revision: 8, Authorised, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Hepsera (updated)
adefovir dipivoxil, Hepatitis B, Chronic
Date of authorisation: 06/03/2003, Revision: 27, Authorised, Last updated: 06/05/2021