80 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Withdrawn application: Opsumit
macitentan, date of withdrawal: 08/11/2019, Post-authorisation, Last updated: 17/02/2020Opsumit: Withdrawn application … Opsumit Opsumit macitentan Macitentan … -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: XInvented name Opsumit Active substance Macitentan … specific waiver for macitentan (Opsumit), (EMEA-001032-PIP02-17 … specific waiver for macitentan (Opsumit), (EMEA-001032-PIP02-17 … -
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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: XInvented name Opsumit Active substance Macitentan … investigation plan for macitentan (Opsumit) (EMEA-001032-PIP01-10-M02 … investigation plan for macitentan (Opsumit) (EMEA-001032-PIP01-10-M02 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001032-PIP03-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 09/07/2021, Last updated: 20/07/2022, Compliance check: XInvented name Opsumit Active substance Macitentan … a waiver for macitentan (Opsumit), (EMEA-001032-PIP03-19 … a waiver for macitentan (Opsumit), (EMEA-001032-PIP03-19 … -
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Human medicine European public assessment report (EPAR): Opsumit
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,
, Revision: 21, Authorised, Last updated: 22/12/2022
Opsumit Respiratory Tract Diseases Lung … 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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Orphan designation: Macitentan for: Treatment of functional single ventricle congenital heart disease
Date of designation: 20/05/2021, Positive, Last updated: 16/03/2022the EU under the trade name Opsumit for the treatment of pulmonary … -
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Orphan designation: Macitentan for: Treatment of chronic thromboembolic pulmonary hypertension
Date of designation: 10/12/2021, Positive, Last updated: 13/04/2022the EU under the trade name Opsumit for the treatment of pulmonary … -
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Human medicine European public assessment report (EPAR): Uptravi
Selexipag, Hypertension, Pulmonary
Date of authorisation: 12/05/2016, Revision: 13, Authorised, Last updated: 01/07/2022 -
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Human medicine European public assessment report (EPAR): Ventavis
iloprost, Hypertension, Pulmonary
Date of authorisation: 15/09/2003, Revision: 29, Authorised, Last updated: 13/12/2021 -
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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: 7, Authorised, Last updated: 09/06/2022
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Human medicine European public assessment report (EPAR): Volibris
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/04/2008, Revision: 22, Authorised, Last updated: 28/09/2021 -
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Human medicine European public assessment report (EPAR): Adempas
riociguat, Hypertension, Pulmonary
Date of authorisation: 27/03/2014, Revision: 12, Authorised, Last updated: 14/06/2022 -
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Human medicine European public assessment report (EPAR): Tracleer
bosentan (as monohydrate), Scleroderma, Systemic; Hypertension, Pulmonary
Date of authorisation: 14/05/2002, Revision: 41, Authorised, Last updated: 29/10/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 February 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/02/2022 to 10/02/2022, Last updated: 07/11/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 October 2021
European Medicines Agency, Amsterdam, the Netherlands, from 25/10/2021 to 28/10/2021, Last updated: 02/08/2022 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 02/02/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 10-13 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/10/2022 to 13/10/2022, Last updated: 23/11/2022 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 27/01/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2022 to 10/06/2022, Last updated: 07/06/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 8-11 November 2021
Online, from 08/11/2021 to 11/11/2021, Last updated: 20/01/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 16-19 May 2022
European Medicines Agency, Amsterdam, the Netherlands, from 16/05/2022 to 19/05/2022, Last updated: 12/08/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2022
European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2022 to 22/04/2022, Last updated: 12/08/2022