125 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Date of refusal: 18/11/2006, Revision: 24, Withdrawn, Last updated: 08/08/2022Withdrawn Agomelatine Overview This is a summary … medicine.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: 30/06/2023, Compliance check: V, 14/10/2022Valdoxan 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 … conditions. bioequivalence of agomelatine oral tablet 25 mg … 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: 22, Authorised, Last updated: 02/08/2023with 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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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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Product-specific bioequivalence guidance
Last updated: 22/06/2023product-specific bioequivalence guidance Agomelatine product-specific bioequivalence …
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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: Tania Schink, European Medicines Agency (updated)
- Declaration of interests - 43.04 KB | PDF
- Curriculum Vitae - 47.19 KB | PDF
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National expert: Antonio Portolés, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 44.8 KB | PDF
- Curriculum Vitae - 54.71 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: 24, Authorised, Last updated: 18/07/2023 -
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National expert: Pieter Colin, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 40.02 KB | PDF
- Curriculum Vitae - 42.69 KB | PDF
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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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PRAC recommendations on safety signals (updated)
Last updated: 25/09/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 11-14 September 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 11/09/2023 to 14/09/2023, Last updated: 14/09/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 June 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 05/06/2023 to 08/06/2023, Last updated: 04/09/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 25/09/2023 -
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Public data from Article 57 database
Last updated: 30/06/2023 -
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Ibuprofen product-specific bioequivalence guidance
Last updated: 22/06/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 23-26 January 2023
European Medicines Agency, Amsterdam, the Netherlands, from 23/01/2023 to 26/01/2023, Last updated: 14/04/2023