3751 results
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Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate for: Treatment of mucopolysaccharidosis type I
Date of designation: 22/09/2016, Positive, Last updated: 24/05/20226'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine … PSO 119-16 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine … orphan designation 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine … -
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Referentials Management Service (RMS)
Last updated: 07/01/2019rentials Management Service (RMS … Referentials Management Service (RMS) to support regulatory activities …
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Introduction to Referentials Management Service (RMS): Industry webinar
Online, 10:30 - 12:30 Amsterdam time (CEST), 21/09/2022, Last updated: 02/08/2022Referentials Management Service (RMS): Industry webinar … Referentials Management Service (RMS): Industry webinar … -
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SPOR and xEVMPD Stakeholder Engagement Webinars : Referentials Management Service (RMS)
Online, 03/10/2023, Last updated: 29/06/2023Referentials Management Service (RMS … Referentials Management Service (RMS): event code … -
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Risk management plans (RMP) in post-authorisation phase: questions and answers
Last updated: 05/07/2023Risk management plans (RMP) in post-authorisation phase … Risk management plans (RMP) in post-authorisation phase …
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Submission of referentials management services (RMS) and organisations management services (OMS) change requests
European Medicines Agency, London, UK, 12/02/2018, Last updated: 27/02/2018referentials management services (RMS) and organisations management … referentials management services (RMS) and organisations management … Submission of RMS & OMS change requests An … -
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Introduction to Organisation Management Service (OMS) and Referentials Management Service (RMS) services and activities: Industry webinar
Online, 10:00 - 12:00 and 14:00 - 16:00 Amsterdam time (CEST), 10/03/2022, Last updated: 01/02/2022Referentials Management Service (RMS) services and activities … Referentials Management Service (RMS) services and activities … -
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Introduction to Organisation Management Service (OMS) / Referentials Management Service (RMS) services and activities: Industry webinar
Online, 10:30-12:30 (CEST); 14:00-16:00 (CEST), 21/10/2021, Last updated: 09/09/2021Referentials Management Service (RMS) services and activities … and Referentials Management Service (RMS) services and activities for industry … 14:00 to 16:00, focuses on RMS: RMS services and activities … -
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European Medicines Agency information day on risk management planning: implementation of GVP V and RMP template rev. 2 guidance
European Medicines Agency, London, UK, 19/12/2017, Last updated: 07/11/2017implementation of GVP V and RMP template rev. 2 guidance … implementation of GVP V and RMP template rev. 2 guidance … implementation of GVP V and RMP template rev. 2 guidance EMA … -
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Using Organisations Management Services (OMS) and Referentials Management Service (RMS) data in electronic application forms (eAF): SPOR webinar
European Medicines Agency, London, UK, 28/11/2017, Last updated: 07/03/2018Referentials Management Service (RMS) data in electronic application … SPOR webinar: Using OMS & RMS data in eAF PDF icon application/pdf … SPOR webinar: Using OMS & RMS data in eAF - webinar 28 … -
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Human medicine European public assessment report (EPAR): Ocrevus
ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018, Revision: 17, Authorised, Last updated: 13/04/2023forms of multiple sclerosis (RMS), where the patient has flare-ups … forms of multiple sclerosis (RMS), the average number of relapses … forms of multiple sclerosis (RMS), where the patient has flare-ups … -
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Human medicine European public assessment report (EPAR): Nerlynx
neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018, Revision: 13, Authorised, Last updated: 15/06/2023 -
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Human medicine European public assessment report (EPAR): Ikervis
ciclosporin, Corneal Diseases
Date of authorisation: 19/03/2015, Revision: 10, Authorised, Last updated: 27/02/2023h-2066-rmpsummary_en.pdf … -
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Human medicine European public assessment report (EPAR): Duaklir Genuair
aclidinium bromide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014,
, Revision: 15, Authorised, Last updated: 11/01/2023
h-3745-rmp_summary_en.pdf … -
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Human medicine European public assessment report (EPAR): Abrysvo (updated)
Respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B, Respiratory Syncytial Virus Infections
Date of authorisation: 23/08/2023,, 
, Authorised, Last updated: 15/09/2023
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Human medicine European public assessment report (EPAR): Lonsurf (updated)
trifluridine, tipiracil hydrochloride, Colorectal Neoplasms
Date of authorisation: 25/04/2016, Revision: 9, Authorised, Last updated: 11/09/2023PDF icon application/pdf rmp_summary_of_the_risk_management_plan_en.pdf 08/10/2019 11/09/2023 Generic … -
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Human medicine European public assessment report (EPAR): Voxzogo (updated)
Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021,, 
, Revision: 3, Authorised, Last updated: 06/09/2023
PDF icon application/pdf rmp_v2.0_part_vi_en.pdf 09/09/2021 Generic This EPAR … -
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Human medicine European public assessment report (EPAR): Regkirona (updated)
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 8, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Tolvaptan Accord
Tolvaptan, Inappropriate ADH Syndrome
, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Tevagrastim
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,
, Revision: 18, Authorised, Last updated: 14/07/2023
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Human medicine European public assessment report (EPAR): Ronapreve
casirivimab, imdevimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 5, Authorised, Last updated: 10/07/2023
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Human medicine European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)
formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 23/04/2018, Revision: 4, Authorised, Last updated: 30/06/2023 -
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Human medicine European public assessment report (EPAR): Prevymis
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, Revision: 15, Authorised, Last updated: 20/06/2023
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Human medicine European public assessment report (EPAR): Duloxetine Mylan (updated)
duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders
Date of authorisation: 19/06/2015,, Revision: 18, Authorised, Last updated: 25/08/2023
h-3981-rmpsummary_en.pdf … -
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Human medicine European public assessment report (EPAR): Aquipta (updated)
atogepant, Migraine Disorders
Date of authorisation: 11/08/2023,, Authorised, Last updated: 25/08/2023
icon application/pdf h-5871-rmp_en.pdf 25/08/2023 Generic This EPAR …