120 results
Keyword agomelatin Remove keyword
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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: 24, Authorised, Last updated: 08/08/2022Authorised Agomelatine Overview This is a summary … medicine. 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): Valdoxan
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009, Revision: 24, Authorised, Last updated: 08/08/2022Authorised Agomelatine Overview This is a summary … medicine. 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 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-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 17/03/2021, Last updated: 23/11/2021, Compliance check: XValdoxan and associated names Agomelatine PsychiatryP/0115/2021EMEA-001181-PIP01-11-M06 … 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 … Agomelatine product-specific bioequivalence … Products for Human Use (CHMP) Agomelatine tablet 25 mg product-specific …
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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: 19, Authorised, Last updated: 13/10/2022with 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: Jogin Thakore, European Medicines Agency (updated)
- Declaration of interests - 83 KB | PDF
- Curriculum Vitae - 30.16 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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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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National expert: Inês Ribeiro-Vaz, National Authority of Medicines and Health Products, I.P. (updated)
- Declaration of interests - 79.85 KB | PDF
- Curriculum Vitae - 22.16 KB | PDF
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Product-specific bioequivalence guidance
Last updated: 06/10/2015guidance - Scientific guideline Agomelatine product-specific bioequivalence …
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National expert: Dolores Montero Corominas, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 26.86 KB | PDF
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National expert: Antonio Portolés, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 82.88 KB | PDF
- Curriculum Vitae - 43.11 KB | PDF
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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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Human medicine European public assessment report (EPAR): Zelboraf
vemurafenib, Melanoma
Date of authorisation: 17/02/2012, Revision: 22, Authorised, Last updated: 24/11/2021 -
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National expert: Pieter Colin, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.41 KB | PDF
- Curriculum Vitae - 30.13 KB | PDF
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PRAC recommendations on safety signals (updated)
Last updated: 06/02/2023 -
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Paediatric Committee (PDCO): 6-9 September 2022
Virtual meeting, from 06/09/2022 to 09/09/2022, Last updated: 26/10/2022 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 06/02/2023 -
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Paediatric Committee (PDCO): 11-14 October 2022
Virtual meeting, from 11/10/2022 to 14/10/2022, Last updated: 12/10/2022 -
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PDCO: Agendas, minutes and reports (updated)
Last updated: 17/01/2023