17385 results
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Human medicine European public assessment report (EPAR): Roteas (updated)
edoxaban tosylate, Stroke, Venous Thromboembolism
Date of authorisation: 19/04/2017,, Revision: 8, Authorised, Last updated: 19/01/2021
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News: Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines
Last updated: 19/01/2021 -
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COVID-19: latest updates (updated)
Last updated: 19/01/2021 -
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International Coalition of Medicines Regulatory Authorities (ICMRA) (updated)
Last updated: 19/01/2021 -
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Human medicine European public assessment report (EPAR): Pradaxa (updated)
Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism
Date of authorisation: 17/03/2008,, Revision: 32, Authorised, Last updated: 19/01/2021
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Eligible patients and consumers organisations (updated)
Last updated: 19/01/2021 -
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Human medicine European public assessment report (EPAR): Cerezyme (updated)
imiglucerase, Gaucher Disease
Date of authorisation: 17/11/1997, Revision: 25, Authorised, Last updated: 18/01/2021 -
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Human medicine European public assessment report (EPAR): Qutavina
teriparatide, Osteoporosis
Date of authorisation: 27/08/2020,, Withdrawn, Last updated: 18/01/2021
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Human medicine European public assessment report (EPAR): Ovitrelle (updated)
choriogonadotropin alfa, Anovulation, Reproductive Techniques, Assisted, Infertility, Female
Date of authorisation: 02/02/2001, Revision: 20, Authorised, Last updated: 18/01/2021 -
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Human medicine European public assessment report (EPAR): Incruse Ellipta (previously Incruse) (updated)
umeclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 28/04/2014,, Revision: 14, Authorised, Last updated: 18/01/2021
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Human medicine European public assessment report (EPAR): Yervoy (updated)
Ipilimumab, Melanoma
Date of authorisation: 12/07/2011, Revision: 35, Authorised, Last updated: 18/01/2021 -
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Human medicine European public assessment report (EPAR): Recarbrio (updated)
imipenem monohydrate, cilastatin sodium, relebactam monohydrate, Gram-Negative Bacterial Infections
Date of authorisation: 13/02/2020,, Revision: 1, Authorised, Last updated: 19/01/2021
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Committee for Orphan Medicinal Products (COMP): 19-21 January 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 19/01/2021 to 21/01/2021, Last updated: 18/01/2021 -
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Withdrawn application: Puldysa (updated)
idebenone, date of withdrawal: 28/10/2020, Initial authorisation, Last updated: 18/01/2021 -
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Fifth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines (updated)
Virtual meeting, 03/12/2020, Last updated: 18/01/2021 -
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Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 November 2020 (updated)
Virtual meeting, from 03/11/2020 to 05/11/2020, Last updated: 18/01/2021 -
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Human medicine European public assessment report (EPAR): Lyxumia (updated)
lixisenatide, Diabetes Mellitus, Type 2
Date of authorisation: 31/01/2013, Revision: 12, Authorised, Last updated: 18/01/2021 -
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Human medicine European public assessment report (EPAR): Dificlir (updated)
fidaxomicin, Clostridium Infections
Date of authorisation: 05/12/2011, Revision: 13, Authorised, Last updated: 18/01/2021 -
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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
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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
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Human medicine European public assessment report (EPAR): Tyverb (updated)
lapatinib, Breast Neoplasms
Date of authorisation: 10/06/2008, Revision: 31, Authorised, Last updated: 15/01/2021 -
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Transparency: exceptional measures for COVID-19 medicines (updated)
Last updated: 15/01/2021 -
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Scientific publications (updated)
Last updated: 15/01/2021 -
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Human medicine European public assessment report (EPAR): Toujeo (previously Optisulin) (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 26/06/2000, Revision: 31, Authorised, Last updated: 15/01/2021 -
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Human medicine European public assessment report (EPAR): Tresiba (updated)
insulin degludec, Diabetes Mellitus
Date of authorisation: 20/01/2013, Revision: 14, Authorised, Last updated: 15/01/2021