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462 results

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Summaries of opinion Remove Summaries of opinion filter Withdrawn applications Remove Withdrawn applications filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Paediatric investigation plans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): Darunavir Krka (updated)

darunavir, HIV Infections
Date of authorisation: 26/01/2018, , Revision: 6, Authorised, Last updated: 27/01/2021
List item

Human medicine European public assessment report (EPAR): Ibandronic Acid Teva (updated)

ibandronic acid, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone, Osteoporosis, Postmenopausal
Date of authorisation: 17/09/2010, , Revision: 10, Authorised, Last updated: 27/01/2021
List item

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

Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016, , , , Revision: 6, Authorised, Last updated: 27/01/2021
List item

Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)

acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome, Myocardial Infarction
Date of authorisation: 09/01/2020, , Revision: 4, Authorised, Last updated: 27/01/2021
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): Actelsar HCT (updated)

telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013, , Revision: 12, Authorised, Last updated: 27/01/2021
List item

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

tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016, , Revision: 11, Authorised, Last updated: 27/01/2021
List item

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

Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016, , , , Revision: 15, Authorised, Last updated: 26/01/2021
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): Takhzyro (updated)

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

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
List item

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

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462 results

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

Human medicine European public assessment report (EPAR): Ibandronic Acid Teva (updated)

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

Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)

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

Human medicine European public assessment report (EPAR): Actelsar HCT (updated)

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

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

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)