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141 results
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Human medicine European public assessment report (EPAR): Ziextenzo (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,
, Revision: 8, Authorised, Last updated: 05/09/2023
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Human medicine European public assessment report (EPAR): Binocrit
epoetin alfa, Anemia; Kidney Failure, Chronic
Date of authorisation: 28/08/2007,, Revision: 21, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Abseamed
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,
Date of refusal: 18/06/2009,, Revision: 22, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Epoetin Alfa Hexal
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,, Revision: 23, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Ovaleap
follitropin alfa, Anovulation
Date of authorisation: 27/09/2013,, Revision: 10, Authorised, Last updated: 18/08/2023
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Human medicine European public assessment report (EPAR): Zabdeno
Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,
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, Revision: 4, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Mvabea
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,, , Revision: 3, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Erelzi
etanercept, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,, Revision: 13, Authorised, Last updated: 04/08/2023
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Human medicine European public assessment report (EPAR): Terrosa
teriparatide, Osteoporosis
Date of authorisation: 04/01/2017,, , Revision: 6, Authorised, Last updated: 28/07/2023
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Human medicine European public assessment report (EPAR): Inhixa
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, Revision: 25, Authorised, Last updated: 27/07/2023
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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: 6, Authorised, Last updated: 26/07/2023
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Human medicine European public assessment report (EPAR): Retacrit
epoetin zeta, Anemia; Blood Transfusion, Autologous; Kidney Failure, Chronic; Cancer
Date of authorisation: 18/12/2007,, Revision: 31, Authorised, Last updated: 26/07/2023
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Human medicine European public assessment report (EPAR): Accofil
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 14, Authorised, Last updated: 24/07/2023
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Human medicine European public assessment report (EPAR): Yuflyma
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: 10, Authorised, Last updated: 18/07/2023
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
Dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,, 
, , Revision: 15, Authorised, Last updated: 18/07/2023
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Human medicine European public assessment report (EPAR): Remsima
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 36, Authorised, Last updated: 17/07/2023
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Human medicine European public assessment report (EPAR): Tevagrastim
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 18, Authorised, Last updated: 14/07/2023
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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: 5, Authorised, Last updated: 14/07/2023
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Human medicine European public assessment report (EPAR): Zessly
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, Revision: 11, Authorised, Last updated: 14/07/2023
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Human medicine European public assessment report (EPAR): Zercepac
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 27/07/2020,, , Revision: 9, Authorised, Last updated: 11/07/2023
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Human medicine European public assessment report (EPAR): Insulin lispro Sanofi
insulin lispro, Diabetes Mellitus
Date of authorisation: 19/07/2017,, Revision: 9, Authorised, Last updated: 07/07/2023
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020,, Revision: 4, Authorised, Last updated: 07/07/2023
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Human medicine European public assessment report (EPAR): Truvelog Mix 30
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/04/2022,, , Revision: 2, Authorised, Last updated: 06/07/2023
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Human medicine European public assessment report (EPAR): Bekemv
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 19/04/2023,, Revision: 1, Authorised, Last updated: 06/07/2023
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Human medicine European public assessment report (EPAR): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,
, , , Revision: 3, Authorised, Last updated: 05/07/2023