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Medicine
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Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 20/07/2011,
, Revision: 17, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Conbriza (updated)
bazedoxifene, Osteoporosis, Postmenopausal
Date of authorisation: 17/04/2009, Revision: 14, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Xelevia (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2007, Revision: 31, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Latuda (updated)
lurasidone, Schizophrenia
Date of authorisation: 21/03/2014, Revision: 21, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Neoclarityn (updated)
desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 39, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Hirobriz Breezhaler (updated)
indacaterol maleate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 30/11/2009, Revision: 17, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Zyprexa Velotab (updated)
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 03/02/2000, Revision: 30, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Ebymect (updated)
dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2015, Revision: 16, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Prepandrix (updated)
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 14/05/2008,
, Revision: 13, Withdrawn, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Januvia (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 20/03/2007, Revision: 28, Authorised, Last updated: 23/02/2021 -
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Human medicine European public assessment report (EPAR): Remsima (updated)
infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,
, Revision: 22, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,
, , Revision: 11, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Hycamtin (updated)
topotecan, Ovarian Neoplasms, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma
Date of authorisation: 12/11/1996, Revision: 32, Authorised, Last updated: 23/02/2021 -
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Human medicine European public assessment report (EPAR): Tecentriq (updated)
atezolizumab, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Urologic Neoplasms, Breast Neoplasms, Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017,, Revision: 12, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Benepali (updated)
etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016,, Revision: 13, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Luveris (updated)
lutropin alfa, Ovulation Induction, Infertility, Female
Date of authorisation: 29/11/2000, Revision: 20, Authorised, Last updated: 23/02/2021 -
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Human medicine European public assessment report (EPAR): Idelvion (updated)
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,, , Revision: 9, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d. (updated)
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017,
, Revision: 7, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Levetiracetam ratiopharm (updated)
levetiracetam, Epilepsy
Date of authorisation: 26/08/2011,, Revision: 11, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Xydalba (updated)
dalbavancin hydrochloride, Soft Tissue Infections, Skin Diseases, Bacterial
Date of authorisation: 19/02/2015, Revision: 12, Authorised, Last updated: 22/02/2021 -
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Human medicine European public assessment report (EPAR): Arixtra (updated)
fondaparinux sodium, Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction, Angina, Unstable
Date of authorisation: 20/03/2002, Revision: 30, Authorised, Last updated: 22/02/2021 -
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Human medicine European public assessment report (EPAR): Nepexto (updated)
etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020,, , Revision: 3, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Kanjinti (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 16/05/2018,, , Revision: 7, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Edurant (updated)
rilpivirine hydrochloride, HIV Infections
Date of authorisation: 28/11/2011, Revision: 18, Authorised, Last updated: 22/02/2021 -
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Human medicine European public assessment report (EPAR): Spinraza (updated)
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, , , Revision: 11, Authorised, Last updated: 22/02/2021