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864 results

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Withdrawn applications Remove Withdrawn applications filter Paediatric investigation plans Remove Paediatric investigation plans filter

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

enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016, , , Revision: 17, Authorised, Last updated: 24/02/2021
List item

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

sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016, , Revision: 11, Authorised, Last updated: 24/02/2021
List item

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

C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011, , Revision: 19, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Rolufta Ellipta (previously Rolufta) (updated)

umeclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 20/03/2017, , Revision: 9, Authorised, Last updated: 24/02/2021
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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): Galafold (updated)

migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016, , , Revision: 11, Authorised, Last updated: 23/02/2021
List item

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
List item

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): 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
List item

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): Spinraza (updated)

nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017, , , , Revision: 11, Authorised, Last updated: 22/02/2021
List item

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

ropeginterferon alfa-2b, Polycythemia Vera
Date of authorisation: 15/02/2019, , Revision: 1, Authorised, Last updated: 22/02/2021
List item

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

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , , , Revision: 20, Authorised, Last updated: 22/02/2021
List item

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

dacomitinib monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 02/04/2019, , Revision: 1, Authorised, Last updated: 22/02/2021
List item

Human medicine European public assessment report (EPAR): Lyumjev (previously Liumjev) (updated)

insulin lispro, Diabetes Mellitus
Date of authorisation: 24/03/2020, , Revision: 2, Authorised, Last updated: 19/02/2021
List item

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

imipenem monohydrate, cilastatin sodium, relebactam monohydrate, Gram-Negative Bacterial Infections
Date of authorisation: 13/02/2020, , Revision: 2, Authorised, Last updated: 19/02/2021
List item

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

Botulinum toxin type A, Skin Aging
Date of authorisation: 27/09/2019, , Revision: 2, Authorised, Last updated: 19/02/2021
List item

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: 11, Authorised, Last updated: 18/02/2021
List item

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

Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018, , , , Revision: 7, Authorised, Last updated: 18/02/2021
List item

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

pancreas powder, Exocrine Pancreatic Insufficiency
Date of authorisation: 29/06/2016, , Revision: 1, Withdrawn, Last updated: 17/02/2021
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Human medicine European public assessment report (EPAR): Piqray (updated)

Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020, , Revision: 2, Authorised, Last updated: 16/02/2021
List item

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

pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018, , , Revision: 3, Withdrawn, Last updated: 15/02/2021
List item

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

ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019, , Revision: 4, Authorised, Last updated: 15/02/2021
List item

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

darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017, , Revision: 9, Authorised, Last updated: 11/02/2021
List item

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

avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017, , Revision: 8, Authorised, Last updated: 11/02/2021

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864 results

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

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

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

Human medicine European public assessment report (EPAR): Rolufta Ellipta (previously Rolufta) (updated)

Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)

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

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

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

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Lyumjev (previously Liumjev) (updated)

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

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

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

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

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

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

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

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

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

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