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549 results

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filter Orphan designations Remove Orphan designations filter Summaries of opinion Remove Summaries of opinion filter Withdrawn applications Remove Withdrawn applications filter Paediatric investigation plans Remove Paediatric investigation plans filter

Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine type Accelerated assessment Remove Accelerated assessment filter Generic Remove Generic filter Exceptional circumstances Remove Exceptional circumstances filter Conditional approval Remove Conditional approval filter

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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): Takhzyro (updated)

lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018, , , , Revision: 4, Authorised, Last updated: 25/01/2021
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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
List item

Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm GmbH (updated)

clopidogrel, Peripheral Vascular Diseases, Acute Coronary Syndrome, Myocardial Infarction, Stroke
Date of authorisation: 28/07/2009, , Revision: 12, Withdrawn, Last updated: 25/01/2021
List item

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

nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015, , Revision: 17, Authorised, Last updated: 25/01/2021
List item

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

ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012, , , Revision: 27, Authorised, Last updated: 22/01/2021
List item

Human medicine European public assessment report (EPAR): Clopidogrel TAD (updated)

clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 23/09/2009, , Revision: 12, Authorised, Last updated: 18/01/2021
List item

Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi (updated)

bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019, , Revision: 3, Authorised, Last updated: 18/01/2021
List item

Human medicine European public assessment report (EPAR): Busulfan Fresenius Kabi (updated)

busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 22/09/2014, , Revision: 8, Authorised, Last updated: 15/01/2021
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Human medicine European public assessment report (EPAR): Grepid (updated)

clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 27/07/2009, , Revision: 21, Authorised, Last updated: 15/01/2021
List item

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

lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015, , , Revision: 14, Authorised, Last updated: 15/01/2021
List item

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

lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016, , , Revision: 12, Authorised, Last updated: 14/01/2021
List item

Human medicine European public assessment report (EPAR): Zonisamide Mylan (updated)

zonisamide, Epilepsy
Date of authorisation: 31/03/2016, , Revision: 5, Authorised, Last updated: 14/01/2021
List item

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
List item

Human medicine European public assessment report (EPAR): Clopidogrel Krka (updated)

clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 23/09/2009, , Revision: 15, Authorised, Last updated: 13/01/2021
List item

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
List item

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: 1, Authorised, Last updated: 12/01/2021
List item

Human medicine European public assessment report (EPAR): Daptomycin Hospira (updated)

daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial
Date of authorisation: 22/03/2017, , Revision: 9, Authorised, Last updated: 08/01/2021
List item

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
List item

Veterinary medicine European public assessment report (EPAR): Meloxidolor (updated)

meloxicam, Horses, Dogs, Cattle, Cats, Pigs
Date of authorisation: 22/04/2013, , Revision: 8, Authorised, Last updated: 07/01/2021
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Human medicine European public assessment report (EPAR): Telmisartan Actavis (updated)

telmisartan, Hypertension
Date of authorisation: 29/09/2010, , Revision: 10, Authorised, Last updated: 05/01/2021
List item

Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)

clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009, , Revision: 15, Authorised, Last updated: 04/01/2021
List item

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
List item

Human medicine European public assessment report (EPAR): Hemlibra

Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018, , , Revision: 7, Authorised, Last updated: 22/12/2020

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549 results

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

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

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

Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm GmbH (updated)

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

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

Human medicine European public assessment report (EPAR): Clopidogrel TAD (updated)

Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi (updated)

Human medicine European public assessment report (EPAR): Busulfan Fresenius Kabi (updated)

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

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

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

Human medicine European public assessment report (EPAR): Zonisamide Mylan (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): Clopidogrel Krka (updated)

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

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

Human medicine European public assessment report (EPAR): Daptomycin Hospira (updated)

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

Veterinary medicine European public assessment report (EPAR): Meloxidolor (updated)

Human medicine European public assessment report (EPAR): Telmisartan Actavis (updated)

Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)

Human medicine European public assessment report (EPAR): Veklury

Human medicine European public assessment report (EPAR): Hemlibra