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Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine Paediatric investigation plans Remove Paediatric investigation plans filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Summaries of opinion Remove Summaries of opinion filter

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

teriparatide, Osteoporosis
Date of authorisation: 11/01/2017, , Revision: 10, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Zynteglo (updated)

Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019, , , , , Revision: 5, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Janssen (updated)

adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021, , , Revision: 16, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Comirnaty (updated)

Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020, , , Revision: 19, Authorised, Last updated: 20/01/2022
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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: 16/11/2021, , Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Voraxaze (updated)

glucarpidase, Metabolic Side Effects of Drugs and Substances
Date of authorisation: 11/01/2022, , , , Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Inhixa (updated)

enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016, , Revision: 21, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Takhzyro (updated)

lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018, , , , Revision: 7, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Evrysdi (updated)

Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021, , , Revision: 1, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Onpattro (updated)

patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018, , , , Revision: 9, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021, , , Revision: 18, Authorised, Last updated: 18/01/2022
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Human medicine European public assessment report (EPAR): Libmyris (updated)

adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Hidradenitis Suppurativa; Crohn Disease; Colitis, Ulcerative; Uveitis
Date of authorisation: 12/11/2021, , Authorised, Last updated: 18/01/2022
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Human medicine European public assessment report (EPAR): Retsevmo (updated)

Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021, , , Revision: 2, Authorised, Last updated: 14/01/2022
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Human medicine European public assessment report (EPAR): Herzuma (updated)

trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018, , , Revision: 14, Authorised, Last updated: 14/01/2022
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Human medicine European public assessment report (EPAR): Semglee (updated)

insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018, , , Revision: 6, Authorised, Last updated: 14/01/2022
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)

6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012, , Revision: 13, Authorised, Last updated: 14/01/2022
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Human medicine European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane) (updated)

Para-aminosalicylic acid, Tuberculosis
Date of authorisation: 07/04/2014, , Revision: 9, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Elzonris (updated)

tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021, , , , Revision: 3, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Artesunate Amivas (updated)

artesunate, Malaria
Date of authorisation: 22/11/2021, , , Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Hulio (updated)

adalimumab, Hidradenitis Suppurativa; Psoriasis; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic
Date of authorisation: 17/09/2018, , , Revision: 10, Authorised, Last updated: 12/01/2022
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Human medicine European public assessment report (EPAR): Scenesse (updated)

afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014, , , , Revision: 8, Authorised, Last updated: 12/01/2022
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Human medicine European public assessment report (EPAR): Ogivri (updated)

trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 12/12/2018, , , Revision: 8, Authorised, Last updated: 12/01/2022
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Human medicine European public assessment report (EPAR): Revestive (updated)

teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012, , , Revision: 17, Authorised, Last updated: 11/01/2022
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Human medicine European public assessment report (EPAR): Increlex (updated)

Mecasermin, Laron Syndrome
Date of authorisation: 02/08/2007, , , Revision: 24, Authorised, Last updated: 11/01/2022
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Human medicine European public assessment report (EPAR): Minjuvi (updated)

Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021, , , , Revision: 2, Authorised, Last updated: 11/01/2022