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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter

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Human medicine European public assessment report (EPAR): Alofisel (updated)

darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018, , , Revision: 5, Authorised, Last updated: 24/11/2020
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Human medicine European public assessment report (EPAR): Orkambi (updated)

Lumacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 18/11/2015, , Revision: 23, Authorised, Last updated: 23/11/2020
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Human medicine European public assessment report (EPAR): Skyrizi (updated)

Risankizumab, Psoriasis
Date of authorisation: 26/04/2019, , Revision: 4, Authorised, Last updated: 23/11/2020
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)

tafamidis, Amyloidosis
Date of authorisation: 16/11/2011, , , , Revision: 17, Authorised, Last updated: 23/11/2020
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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, , , Revision: 13, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Darzalex (updated)

Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016, , , , Revision: 14, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Mysimba (updated)

bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight
Date of authorisation: 26/03/2015, , Revision: 17, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Ondexxya (updated)

andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019, , , Revision: 6, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Cablivi (updated)

Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018, , , Revision: 4, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Myalepta (updated)

Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018, , , , Revision: 4, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Zavicefta (updated)

avibactam sodium, ceftazidime pentahydrate, Pneumonia, Bacterial, Soft Tissue Infections, Pneumonia, Urinary Tract Infections, Gram-Negative Bacterial Infections
Date of authorisation: 23/06/2016, , Revision: 10, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Polivy (updated)

polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020, , , , Revision: 1, Authorised, Last updated: 19/11/2020
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Human medicine European public assessment report (EPAR): Gilenya (updated)

fingolimod hydrochloride , Multiple Sclerosis
Date of authorisation: 17/03/2011, , , Revision: 26, Authorised, Last updated: 19/11/2020
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Human medicine European public assessment report (EPAR): Inflectra (updated)

infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 26, Authorised, Last updated: 18/11/2020
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Human medicine European public assessment report (EPAR): Ofev (updated)

nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015, , Revision: 15, Authorised, Last updated: 18/11/2020
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)

Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Hawaii/70/2019 (H1N1)pdm09-like strain (A/Nebraska/14/2019, wild type); A/Hong Kong/45/2019 (H3N2)-like strain (A/Delaware/39/2019, wild type); B/Washington/02/2019-like strain (B/Darwin/7/2019, wild type); B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018, , Revision: 6, Authorised, Last updated: 18/11/2020
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Human medicine European public assessment report (EPAR): Keytruda (updated)

Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 17/07/2015, , Revision: 29, Authorised, Last updated: 17/11/2020
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Human medicine European public assessment report (EPAR): Glyxambi (updated)

empagliflozin, linagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 11/11/2016, , Revision: 11, Authorised, Last updated: 16/11/2020
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Human medicine European public assessment report (EPAR): Equidacent (updated)

bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
Date of authorisation: 24/09/2020, , , Revision: 1, Authorised, Last updated: 16/11/2020
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Human medicine European public assessment report (EPAR): Besponsa (updated)

inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 28/06/2017, , , Revision: 7, Authorised, Last updated: 16/11/2020
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Human medicine European public assessment report (EPAR): Isentress (updated)

Raltegravir, HIV Infections
Date of authorisation: 19/12/2007, , Revision: 37, Authorised, Last updated: 16/11/2020
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Human medicine European public assessment report (EPAR): Talzenna (updated)

talazoparib, Breast Neoplasms
Date of authorisation: 20/06/2019, , Revision: 3, Authorised, Last updated: 13/11/2020
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Human medicine European public assessment report (EPAR): Nubeqa (updated)

darolutamide, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 27/03/2020, , Revision: 2, Authorised, Last updated: 13/11/2020
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Human medicine European public assessment report (EPAR): Glivec (updated)

imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001, , Revision: 39, Authorised, Last updated: 13/11/2020
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Human medicine European public assessment report (EPAR): Nerlynx (updated)

neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018, , Revision: 6, Authorised, Last updated: 13/11/2020