3447 results
Keyword Sinemet RM Remove keyword
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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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Risk management plans (RMP) in post-authorisation phase: questions and answers
Last updated: 13/01/2021Risk management plans (RMP) in post-authorisation phase … the 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: 13, Authorised, Last updated: 04/02/2022
forms 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): 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): Pregabalin Sandoz GmbH
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 11, Authorised, Last updated: 21/04/2022
h-4070-rmp_summary_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: 12, Authorised, Last updated: 20/04/2022
h-4010-rmp_summary_en.pdf … -
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Human medicine European public assessment report (EPAR): Vaxelis
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: 10, Authorised, Last updated: 06/04/2022h-3982_-_rmp_summary_part_vi_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: 13, Authorised, Last updated: 23/06/2021
h-3745-rmp_summary_en.pdf … -
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National expert: Martin Wabitsch, European Medicines Agency (updated)
- Declaration of interests - 81.82 KB | PDF
- Curriculum Vitae - 17.8 KB | PDF
10/2019-(current) Rhythm RM-493-014 Setmelanotide Patients with … 11/2017-(current) Rhythm RM-493-015 Setmelanotide Patients with … 08/2019-(current) Rhythm RM-493-022 Setmelanotide Patients with … -
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Human medicine European public assessment report (EPAR): Ponvory (updated)
ponesimod, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 19/05/2021,, Revision: 2, Authorised, Last updated: 31/05/2022
forms of multiple sclerosis (RMS) with active disease defined … -
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Human medicine European public assessment report (EPAR): Kesimpta
ofatumumab, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 26/03/2021,, Revision: 2, Authorised, Last updated: 24/03/2022
forms of multiple sclerosis (RMS) with active disease defined … of risk management plan (RMP) for Kesimpta®. The RMP details important risks … used. This summary of the RMP for Kesimpta® should be … -
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Human medicine European public assessment report (EPAR): Desloratadine ratiopharm (updated)
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,, Revision: 12, Authorised, Last updated: 24/06/2022
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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 … -
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Human medicine European public assessment report (EPAR): Givlaari (updated)
Givosiran, Porphyrias, Hepatic
Date of authorisation: 02/03/2020,, 
, Revision: 4, Authorised, Last updated: 22/06/2022
icon application/pdf h-4775-rmp_summary_en.pdf 09/03/2020 22/06/2022 Generic … -
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Human medicine European public assessment report (EPAR): LysaKare (updated)
L-arginine hydrochloride, L-lysine hydrochloride, Radiation Injuries
Date of authorisation: 25/07/2019, Revision: 2, Authorised, Last updated: 23/06/2022 -
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Human medicine European public assessment report (EPAR): Orgovyx (updated)
relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022,, Revision: 2, Authorised, Last updated: 10/06/2022
icon application/pdf h-5353-rmp-summary_en.pdf 10/05/2022 … -
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Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan (updated)
lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016,, Revision: 14, Authorised, Last updated: 09/06/2022
h-4025-rmpsummary_en.pdf … -
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Human medicine European public assessment report (EPAR): Otezla
apremilast, Arthritis, Psoriatic; Psoriasis
Date of authorisation: 15/01/2015, Revision: 18, Authorised, Last updated: 20/05/2022h-3746-rmpsummary_en.pdf …