3674 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 … Limited, United Kingdom, for 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine … authorisation . Key facts 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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National expert: R.M. (Ragna) de Schipper, Medicines Evaluation Board (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 16.49 KB | PDF
R.M. (Ragna) de Schipper … R.M. (Ragna) de Schipper … Vitae PERSONAL INFORMATION R.M. (Ragna) de Schipper WORK … -
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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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Risk management plans (RMP) in post-authorisation phase: questions and answers
Last updated: 13/01/2021Risk management plans (RMP) in post-authorisation phase … medicines. risk management plan (RMP) lifecycle during the post … classification of changes to the RMP, submission requirements and …
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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: 14, Authorised, Last updated: 03/10/2022forms 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): Duaklir Genuair (updated)
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): Pregabalin Sandoz GmbH
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,
, Revision: 14, Authorised, Last updated: 05/01/2023
h-4070-rmp_summary_en.pdf … -
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Human medicine European public assessment report (EPAR): Trogarzo (updated)
Ibalizumab, HIV Infections
Date of authorisation: 26/09/2019,, Revision: 7, Withdrawn, Last updated: 16/01/2023
icon application/pdf h-4961-rmp_en.pdf 10/10/2019 16/01/2023 Generic … -
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Human medicine European public assessment report (EPAR): Duloxetine Mylan
duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders
Date of authorisation: 19/06/2015,, Revision: 17, Authorised, Last updated: 25/04/2022
h-3981-rmpsummary_en.pdf … -
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Human medicine European public assessment report (EPAR): Pirfenidone Viatris (updated)
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 10/01/2023,, Authorised, Last updated: 17/01/2023
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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: 13/12/2022 -
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Human medicine European public assessment report (EPAR): Regkirona
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 6, Authorised, Last updated: 12/12/2022
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Human medicine European public assessment report (EPAR): Vyvgart
Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022,, 
, Revision: 2, Authorised, Last updated: 22/11/2022
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Human medicine European public assessment report (EPAR): Vaxelis (updated)
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3, hepatitis B surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein., Meningitis, Haemophilus; Poliomyelitis; Tetanus; Diphtheria; Whooping Cough; Hepatitis B
Date of authorisation: 15/02/2016, Revision: 13, Authorised, Last updated: 17/01/2023h-3982_-_rmp_summary_part_vi_en.pdf … -
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 15, Authorised, Last updated: 05/01/2023
h-4010-rmp_summary_en.pdf … -
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Human medicine European public assessment report (EPAR): Bretaris Genuair
aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 20/07/2012,, Revision: 18, Authorised, Last updated: 05/01/2023
icon application/pdf h-2706-rmp_summary_en.pdf 02/07/2021 02/07/2021 Generic … -
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan
acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 09/01/2020,, Revision: 4, Authorised, Last updated: 02/08/2022
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Human medicine European public assessment report (EPAR): Scenesse
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,, , 
, Revision: 9, Authorised, Last updated: 04/11/2022
h-2548-rmpsummary_en.pdf … -
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Human medicine European public assessment report (EPAR): Brinavess
Vernakalant hydrochloride, Atrial Fibrillation
Date of authorisation: 01/09/2010, Revision: 16, Authorised, Last updated: 03/03/2022accordingly. Update of the RMP to version 7.0 to incorporate … a category 3 study in the RMP (PASS Protocol 6621- 049 …