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345 results
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,
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, Revision: 21, Authorised, Last updated: 25/05/2022
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Human medicine European public assessment report (EPAR): Amifampridine SERB (updated)
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): Dimethyl fumarate Mylan (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Polpharma (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Neuraxpharm (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (updated)
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 8, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Imatinib Teva (updated)
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013,, Revision: 17, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Rubraca (updated)
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,, , Revision: 8, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan (updated)
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,, Revision: 15, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Pregabalin Mylan (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015,, Revision: 13, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Apixaban Accord (updated)
Apixaban, Venous Thromboembolism; Stroke; Arthroplasty
Date of authorisation: 23/07/2020,, Revision: 2, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Duloxetine Zentiva (updated)
duloxetine, Neuralgia; Depressive Disorder, Major; Anxiety Disorders; Diabetes Mellitus
Date of authorisation: 20/08/2015,, Revision: 10, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, , Revision: 11, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (updated)
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 8, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019,, Revision: 7, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Leflunomide ratiopharm (updated)
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 28/11/2010,, Revision: 16, Authorised, Last updated: 17/05/2022
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Human medicine European public assessment report (EPAR): Leflunomide medac (updated)
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010,, Revision: 16, Authorised, Last updated: 16/05/2022
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Human medicine European public assessment report (EPAR): Anagrelide Mylan (updated)
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 5, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Arsenic trioxide Mylan (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 01/04/2020,, Revision: 3, Authorised, Last updated: 13/05/2022
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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: 22, Authorised, Last updated: 12/05/2022
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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: 25, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 2, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , , Revision: 19, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,, Revision: 13, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Arsenic trioxide Accord (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 14/11/2019,, Revision: 5, Authorised, Last updated: 12/05/2022