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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter

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

adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017, , Revision: 18, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Yuflyma (updated)

adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 11/02/2021, , Revision: 8, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Tegsedi (updated)

inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018, , , , Revision: 11, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Hukyndra (updated)

adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 15/11/2021, , Revision: 2, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Zirabev (updated)

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019, , , Revision: 11, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Ontruzant (updated)

trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 15/11/2017, , Revision: 13, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Ziextenzo (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018, , , Revision: 5, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Aybintio (updated)

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020, , , Revision: 5, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Onbevzi (updated)

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 11/01/2021, , , Revision: 2, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Filgrastim Hexal (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009, , Revision: 18, Authorised, Last updated: 15/07/2022
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Human medicine European public assessment report (EPAR): Zarzio (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009, , Revision: 19, Authorised, Last updated: 15/07/2022
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Human medicine European public assessment report (EPAR): Mvasi (updated)

bevacizumab, Carcinoma, Renal Cell; Peritoneal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Fallopian Tube Neoplasms
Date of authorisation: 15/01/2018, , , Revision: 12, Authorised, Last updated: 14/07/2022
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Human medicine European public assessment report (EPAR): Blitzima (updated)

rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017, , Revision: 15, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Darzalex (updated)

Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016, , , Revision: 19, Authorised, Last updated: 11/07/2022
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Human medicine European public assessment report (EPAR): Zynteglo

Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019, , , , , , Revision: 5, Withdrawn, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Exviera

dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, , Revision: 24, Authorised, Last updated: 07/07/2022
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Human medicine European public assessment report (EPAR): Harvoni

ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014, , Revision: 25, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Sovaldi

Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014, , Revision: 25, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Epclusa

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , Revision: 18, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Alymsys

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021, , , Revision: 3, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Oyavas

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021, , , Revision: 3, Authorised, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Inhixa

enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016, , Revision: 21, Authorised, Last updated: 01/07/2022
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Human medicine European public assessment report (EPAR): Bemfola

follitropin alfa, Anovulation
Date of authorisation: 26/03/2014, , Revision: 9, Authorised, Last updated: 28/06/2022
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Human medicine European public assessment report (EPAR): Accofil

filgrastim, Neutropenia
Date of authorisation: 17/09/2014, , Revision: 13, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Kanuma

sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015, , , , Revision: 8, Authorised, Last updated: 21/06/2022