61 results
Keyword Opsumit Remove keyword
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Withdrawn application: Opsumit
macitentan, date of withdrawal: 08/11/2019, Post-authorisation, Last updated: 17/02/2020Opsumit: Withdrawn application … Opsumit Opsumit macitentan Macitentan … -
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Orphan designation: Macitentan for: Treatment of pulmonary arterial hypertension
Date of designation: 27/09/2011, Positive, Last updated: 12/10/2018been authorised in the EU as Opsumit since 20 December 2013 … Update: Macitentan (Opsumit) has been authorised in the … EU since 20 December 2013. Opsumit, as monotherapy or in combination … -
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Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001032-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Film-coated tablet
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: XKey facts Opsumit Macitentan Cardiovascular … product-specific waiver for macitentan (Opsumit), (EMEA-001032-PIP02-17 … 28/09/2017 EMA/459094/2017 Generic Opsumit: EPAR … -
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Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001032-PIP01-10-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Film-coated tablet
Decision date: 18/03/2016, Last updated: 26/04/2016, Compliance check: XKey facts Opsumit Macitentan Cardiovascular … investigation plan for macitentan (Opsumit) (EMEA-001032-PIP01-10-M02 … 26/04/2016 EMA/133062/2016 Generic Opsumit: EPAR … -
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Human medicine European public assessment report (EPAR): Opsumit
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,
, Revision: 18, Authorised, Last updated: 18/06/2021
Opsumit Hypertension, Pulmonary … thorised macitentan Overview Opsumit is a medicine used for the … breathlessness and fatigue. Opsumit is used for adults whose … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 October 2013
CHMP, Last updated: 25/10/2013Opsumit … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2019 (updated)
CHMP, Last updated: 15/11/2019Opsumit … -
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Human medicine European public assessment report (EPAR): Volibris
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/04/2008, Revision: 21, Authorised, Last updated: 07/05/2021 -
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Human medicine European public assessment report (EPAR): Uptravi
Selexipag, Hypertension, Pulmonary
Date of authorisation: 12/05/2016, Revision: 12, Authorised, Last updated: 23/03/2021 -
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Human medicine European public assessment report (EPAR): Ventavis
iloprost, Hypertension, Pulmonary
Date of authorisation: 15/09/2003, Revision: 28, Authorised, Last updated: 01/02/2021 -
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Human medicine European public assessment report (EPAR): Tracleer (updated)
bosentan (as monohydrate), Scleroderma, Systemic, Hypertension, Pulmonary
Date of authorisation: 14/05/2002, Revision: 40, Authorised, Last updated: 21/07/2021 -
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Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,
, Revision: 5, Authorised, Last updated: 01/12/2020
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Human medicine European public assessment report (EPAR): Adempas
riociguat, Hypertension, Pulmonary
Date of authorisation: 27/03/2014,, Revision: 10, Authorised, Last updated: 29/04/2019
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Parallel distribution: Regulatory and procedural guidance
Last updated: 09/06/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2021 to 10/06/2021, Last updated: 07/06/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2021
European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2021 to 22/04/2021, Last updated: 19/04/2021 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 05/07/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 May 2018
European Medicines Agency, London, UK, from 14/05/2018 to 17/05/2018, Last updated: 14/05/2018 -
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EMA/FDA/Health Canada joint workshop addressing unmet needs of children with pulmonary arterial hypertension
European Medicines Agency, London, UK, from 12/06/2017 to 13/06/2017, Last updated: 20/06/2017 -
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Committee for Orphan Medicinal Products (COMP): 8-10 October 2013
European Medicines Agency, London, UK, from 08/10/2013 to 10/10/2013, Last updated: 08/05/2012 -
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Committee for Medicinal Products for Human Use (CHMP): 25-29 January 2021
Virtual meeting, from 25/01/2021 to 29/01/2021, Last updated: 04/03/2021 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 09/07/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 November 2014
European Medicines Agency, London, UK, from 03/11/2014 to 06/11/2014, Last updated: 13/08/2013 -
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Medicines for human use under evaluation 2014–2012
Last updated: 02/06/2021 -
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Committee for Orphan Medicinal Products (COMP): 5-6 November 2013
European Medicines Agency, London, UK, from 05/11/2013 to 06/11/2013, Last updated: 08/05/2012