110 results
Keyword agomelatin Remove keyword
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Human medicine European public assessment report (EPAR): Valdoxan
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009, Revision: 22, Authorised, Last updated: 14/01/2021Authorised Agomelatine Overview This is a summary … contains the active substance agomelatine. How is Valdoxan used? Valdoxan … active substance in Valdoxan, agomelatine, is an antidepressant. It … -
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Human medicine European public assessment report (EPAR): Thymanax
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009,
Date of refusal: 18/11/2006, Revision: 22, Authorised, Last updated: 14/01/2021Authorised Agomelatine Overview This is a summary … contains the active substance agomelatine. How is Thymanax used? Thymanax … active substance in Thymanax, agomelatine, is an antidepressant. It … -
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Human medicine European public assessment report (EPAR): Thymanax
Agomelatine, Depressive Disorder, Major
Date of refusal: 16/01/2007, Refused, Last updated: 27/07/2006Refused Agomelatine Overview On 27 July 2006 … International Nonproprietary Name: Agomelatine Procedure No. EMEA/H/C/656 … 5/39 About the product Agomelatine is a new chemical entity … -
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Human medicine European public assessment report (EPAR): Valdoxan
Agomelatine, Depressive Disorder, Major
Date of refusal: 16/01/2007, Refused, Last updated: 27/07/2006Refused Agomelatine Overview On 27 July 2006 … International Nonproprietary Name: Agomelatine Procedure No. EMEA/H/C/656 … About the product Agomelatine is a new chemical entity … -
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Opinion/decision on a Paediatric investigation plan (PIP): Agomelatine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001181-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 06/12/2019, Last updated: 01/04/2020, Compliance check: XValdoxan and associated names Agomelatine PsychiatryP/0432/2019EMEA-001181-PIP01-11-M05 … paediatric investigation plan for agomelatine (Valdoxan and associated … Agomelatine … -
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Agomelatine product-specific bioequivalence guidance
Last updated: 31/01/2018Agomelatine product-specific bioequivalence … Bioequivalence, generics, agomelatine …
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Press release: EMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine)
CHMP, Last updated: 26/09/2014antidepressant Valdoxan/Thymanax (agomelatine … taking Valdoxan/Thymanax (agomelatine), used to treat major depression … antidepressant Valdoxan/Thymanax (agomelatine) Measures introduced to … -
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Human medicine European public assessment report (EPAR): Brintellix
Vortioxetine, Depressive Disorder, Major
Date of authorisation: 18/12/2013, Revision: 16, Authorised, Last updated: 15/01/2021with another antidepressant, agomelatine, Brintellix was more effective … Brintellix was more effective than agomelatine in improving the symptom … with another antidepressant, agomelatine, Brintellix was more effective … -
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National expert: Ana Isabel Terleira Fernandez, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 86.19 KB | PDF
- Curriculum Vitae - 31.28 KB | PDF
Antiarrhythmic 11/2006-01/2007 Servier Agomelatine Antidepressant 09/2003-10/2003 … -
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National expert: Philip Gorwood, European Medicines Agency (updated)
- Declaration of interests - 81.93 KB | PDF
- Curriculum Vitae - 66.45 KB | PDF
01/2009-(current) Servier Agomelatine Major depressive disorder … 01/2009-06/2019 Servier Agomelatine Major depressive disorder Gorwood … -
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National expert: Jogin Thakore, European Medicines Agency (updated)
- Declaration of interests - 82.96 KB | PDF
- Curriculum Vitae - 30.04 KB | PDF
01/2009-12/2012 Servier Agomelatine Depression 01/2000-12/2012 … Indication 09/2014-08/2015 Servier Agomelatine Depression 12/2002-12/2004 … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 September 2014
PRAC, Last updated: 12/09/2014review of Valdoxan/Thymanax (agomelatine … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 24-27 July 2006
CHMP, Last updated: 28/07/2006agomelatine) and … negative opinions for Valdoxan (agomelatine) and Thymanax agomelatine), both from Les Laboratoires … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014
CHMP, Last updated: 26/09/2014Valdoxan / Thymanax INN agomelatine Marketing-authorisation holder … antidepressant Valdoxan/Thymanax (agomelatine … -
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National expert: Belen Ruiz Antorán, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 88.38 KB | PDF
- Curriculum Vitae - 24.43 KB | PDF
Indication 01/2008-10/2008 Servier Agomelatine Tolerability in healthy volunteers … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013
CHMP, Last updated: 20/09/2013Thymanax INN agomelatine Marketing-authorisation holder … -
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Human medicine European public assessment report (EPAR): Zelboraf
vemurafenib, Melanoma
Date of authorisation: 17/02/2012, Revision: 20, Authorised, Last updated: 31/03/2021 -
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National expert: Pieter Colin, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.17 KB | PDF
- Curriculum Vitae - 27.84 KB | PDF
population pharmacokinetic model of agomelatine and its metabolites in Chinese … -
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Product-specific bioequivalence guidance
Last updated: 06/10/2015product-specific bioequivalence guidance Agomelatine product-specific bioequivalence …
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Workshop on measuring the impact of pharmacovigilance activities
European Medicines Agency, London, UK, from 05/12/2016 to 06/12/2016, Last updated: 27/03/2017monitoring in patients receiving agomelatine in the EHI database (Maia … -
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Herbal medicinal product: Hyperici herba
Hypericum perforatum L., St. John's Wort, P: Draft published, Last updated: 16/04/2021 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2021 -
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Public data from Article 57 database (updated)
Last updated: 02/06/2021 -
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Paediatric Committee (PDCO): 26-29 January 2021
Virtual meeting, from 26/01/2021 to 29/01/2021, Last updated: 11/03/2021 -
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PRAC recommendations on safety signals
Last updated: 03/05/2021