145 results
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Human medicine European public assessment report (EPAR): Rivastigmine Sandoz
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 10/12/2009, Revision: 13, Authorised, Last updated: 13/10/2022 -
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Human medicine European public assessment report (EPAR): Rivastigmine Hexal
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/12/2009, Revision: 14, Authorised, Last updated: 13/10/2022 -
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Human medicine European public assessment report (EPAR): Brintellix
Vortioxetine, Depressive Disorder, Major
Date of authorisation: 18/12/2013, Revision: 21, Authorised, Last updated: 31/03/2023 -
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,
, Revision: 26, Authorised, Last updated: 13/04/2023
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Human medicine European public assessment report (EPAR): Rasagiline Mylan
rasagiline tartrate, Parkinson Disease
Date of authorisation: 04/04/2016,
, Revision: 7, Authorised, Last updated: 23/02/2023
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Human medicine European public assessment report (EPAR): Methylthioninium chloride Proveblue
methylthioninium chloride, Methemoglobinemia
Date of authorisation: 06/05/2011, Revision: 25, Authorised, Last updated: 15/12/2022 -
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Human medicine European public assessment report (EPAR): Palonosetron Hospira
palonosetron hydrochloride, Nausea; Vomiting; Cancer
Date of authorisation: 08/04/2016,, Revision: 4, Withdrawn, Last updated: 08/04/2022
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Human medicine European public assessment report (EPAR): Brilique
Ticagrelor, Peripheral Vascular Diseases; Acute Coronary Syndrome
Date of authorisation: 03/12/2010, Revision: 20, Authorised, Last updated: 26/04/2022 -
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Human medicine European public assessment report (EPAR): Rubraca
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,
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, Revision: 12, Authorised, Last updated: 24/04/2023
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Human medicine European public assessment report (EPAR): Amifampridine SERB
amifampridine phosphate, Lambert-Eaton Myasthenic Syndrome; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Neuromuscular Diseases; Neuromuscular Junction Diseases; Immune System Diseases; Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Cancer; Neoplasms
Date of authorisation: 19/05/2022,, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,, 
, Revision: 34, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Diacomit
stiripentol, Myoclonic Epilepsy, Juvenile
Date of authorisation: 03/01/2007,
Date of refusal: 11/02/2009, Revision: 17, Authorised, Last updated: 15/06/2021 -
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Human medicine European public assessment report (EPAR): Spikevax (previously 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,, , Revision: 37, Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Zubsolv
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 10/11/2017, Revision: 8, Authorised, Last updated: 29/07/2022 -
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Human medicine European public assessment report (EPAR): Rivastigmine Actavis
rivastigmine hydrogen tartrate, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 16/06/2011,, Revision: 16, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Palonosetron Accord
Palonosetron, Vomiting; Nausea; Cancer
Date of authorisation: 26/05/2016,, Revision: 5, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Azilect
rasagiline, Parkinson Disease
Date of authorisation: 21/02/2005, Revision: 22, Authorised, Last updated: 14/01/2022 -
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Human medicine European public assessment report (EPAR): Yentreve
duloxetine hydrochloride, Urinary Incontinence, Stress
Date of authorisation: 11/08/2004, Revision: 28, Authorised, Last updated: 21/12/2021sertraline, paroxetine, citalopram, escitalopram, atomoxetine … -
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Human medicine European public assessment report (EPAR): Lumeblue (previously known as Methylthioninium chloride Cosmo)
methylthioninium chloride, Colorectal Neoplasms; Colonoscopy
Date of authorisation: 19/08/2020, Revision: 2, Authorised, Last updated: 16/06/2021 -
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Human medicine European public assessment report (EPAR): Buvidal
buprenorphine, Opioid-Related Disorders
Date of authorisation: 20/11/2018, Revision: 6, Authorised, Last updated: 21/10/2021 -
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , Revision: 28, Authorised, Last updated: 17/02/2023
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Human medicine European public assessment report (EPAR): Pradaxa
Dabigatran etexilate mesilate, Arthroplasty, Replacement; Venous Thromboembolism
Date of authorisation: 17/03/2008, Revision: 39, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Invanz
ertapenem sodium, Community-Acquired Infections; Streptococcal Infections; Staphylococcal Infections; Gram-Negative Bacterial Infections; Surgical Wound Infection; Pneumonia, Bacterial
Date of authorisation: 18/04/2002, Revision: 26, Authorised, Last updated: 25/10/2022 -
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Human medicine European public assessment report (EPAR): Rasagiline ratiopharm
rasagiline, Parkinson Disease
Date of authorisation: 12/01/2015, Revision: 8, Authorised, Last updated: 05/11/2021 -
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Human medicine European public assessment report (EPAR): Nodetrip (previously Xeristar)
duloxetine, Anxiety Disorders; Depressive Disorder, Major; Diabetic Neuropathies
Date of authorisation: 17/12/2004, Revision: 32, Withdrawn, Last updated: 22/06/2021