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114 results

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Withdrawn applications Remove Withdrawn applications filter Referrals Remove Referrals filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Paediatric investigation plans Remove Paediatric investigation plans filter

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

defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013, , , , Revision: 13, Authorised, Last updated: 28/01/2021
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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: 3, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Lorviqua (updated)

Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019, , , Revision: 5, Authorised, Last updated: 28/01/2021
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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: 2, Authorised, Last updated: 28/01/2021
List item

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

Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013, , , Revision: 13, Authorised, Last updated: 27/01/2021
List item

Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)

CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) 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: 06/01/2021, , , Authorised, Last updated: 26/01/2021
List item

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

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 8, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Rubraca (updated)

rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018, , , Revision: 5, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Holoclar (updated)

ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation, Corneal Diseases
Date of authorisation: 17/02/2015, , , , Revision: 7, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Foclivia (updated)

influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009, , Revision: 10, Authorised, Last updated: 13/01/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , , , Revision: 8, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Veklury

remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020, , , Revision: 4, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Adcetris

Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012, , , , Revision: 28, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Deltyba

Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013, , , , Revision: 14, Authorised, Last updated: 17/12/2020
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Human medicine European public assessment report (EPAR): Polivy

polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020, , , , Revision: 2, Authorised, Last updated: 15/12/2020
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Human medicine European public assessment report (EPAR): Blenrep

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Authorised, Last updated: 15/12/2020
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Human medicine European public assessment report (EPAR): Imvanex

modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine
Date of authorisation: 31/07/2013, , , Revision: 18, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Myalepta

Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018, , , , Revision: 5, Authorised, Last updated: 10/12/2020
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Human medicine European public assessment report (EPAR): Caprelsa

Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012, , , Revision: 18, Authorised, Last updated: 07/12/2020
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Human medicine European public assessment report (EPAR): Libtayo

Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019, , , Revision: 5, Authorised, Last updated: 07/12/2020
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Human medicine European public assessment report (EPAR): Atriance

nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007, , , Revision: 24, Authorised, Last updated: 04/12/2020
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Human medicine European public assessment report (EPAR): Evoltra

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006, , , Revision: 29, Authorised, Last updated: 30/11/2020
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Human medicine European public assessment report (EPAR): Scenesse

afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014, , , , Revision: 7, Authorised, Last updated: 30/11/2020
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Human medicine European public assessment report (EPAR): Obizur

susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015, , , Revision: 6, Authorised, Last updated: 27/11/2020
List item

Human medicine European public assessment report (EPAR): Firdapse (previously Zenas)

amifampridine, Lambert-Eaton Myasthenic Syndrome
Date of authorisation: 23/12/2009, , , Revision: 20, Authorised, Last updated: 26/11/2020

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114 results

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

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

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

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

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

Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)

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

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

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

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

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

Human medicine European public assessment report (EPAR): Veklury

Human medicine European public assessment report (EPAR): Adcetris

Human medicine European public assessment report (EPAR): Deltyba

Human medicine European public assessment report (EPAR): Polivy

Human medicine European public assessment report (EPAR): Blenrep

Human medicine European public assessment report (EPAR): Imvanex

Human medicine European public assessment report (EPAR): Myalepta

Human medicine European public assessment report (EPAR): Caprelsa

Human medicine European public assessment report (EPAR): Libtayo

Human medicine European public assessment report (EPAR): Atriance

Human medicine European public assessment report (EPAR): Evoltra

Human medicine European public assessment report (EPAR): Scenesse

Human medicine European public assessment report (EPAR): Obizur

Human medicine European public assessment report (EPAR): Firdapse (previously Zenas)