172 results
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News: Pharmacovigilance Risk Assessment Committee (PRAC) invites stakeholders' feedback in review of Diane 35 and its generics
PRAC, Last updated: 12/02/2013inviting all stakeholders, e.g., healthcare professionals … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2016
PRAC, Last updated: 15/01/2016pharmacovigilance processes (e.g. spontaneous reporting of … engagement of key stakeholders (e.g. patients, healthcare professionals … measurable health outcomes (e.g. reduction of harm from adverse … -
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News: Benefits of ifosfamide solutions continue to outweigh risks EMA’s safety committee (PRAC) has concluded that the benefits of ifosfamide solutions for infusion (new)
PRAC, Last updated: 12/03/2021generic formulation (IFOSFAMIDE EG®). J Clin Pharm Ther. 2019;44:372–380 … -
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Press release: Review of oral methadone medicines containing povidone started
PRAC, Last updated: 11/04/2014invites all stakeholders (e.g. healthcare professionals … invites all stakeholders (e.g. healthcare professionals … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2017
PRAC, Last updated: 27/10/2017invites all stakeholders (e.g. healthcare professionals … http://www.efsa.europa.eu) EGA European Generic Medicines … Medicines Association (http://www.egagenerics.com) EMA European Medicines … -
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Press release: Listening to the public's views on the safety of medicines
PRAC, Last updated: 15/04/2016stage of a safety review, e.g. through stakeholder submissions … stage of a safety review, e.g. through stakeholder submissions … -
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Press release: Updated recommendations to minimise the risk of the rare brain infection PML with Tysabri
PRAC, Last updated: 12/02/2016more frequent MRI scans (e.g. every 3 to 6 months) should … more frequent MRI scans (e.g. every 3 to 6 months) should … -
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Press release: PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig
PRAC, Last updated: 10/10/2014included additional warnings (e.g. against use in patients … included additional warnings (e.g. against use in patients … -
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News: European Medicines Agency launches public consultation on rules of procedures for public hearings
PRAC, Last updated: 24/07/2014stage of a safety review, e.g. through stakeholder submissions … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October 2020
PRAC, Last updated: 02/10/2020by other factors as well, e.g. diabetes; importantly, COVID-19 … http://www.efsa.europa.eu) EGA European Generic Medicines … Medicines Association (http://www.egagenerics.com) EMA European Medicines … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 November 2020
PRAC, Last updated: 27/11/2020experience mental health problems (e.g. irrational thoughts, anxiety … http://www.efsa.europa.eu) EGA European Generic Medicines … Medicines Association (http://www.egagenerics.com) EMA European Medicines … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 March 2021 (new)
PRAC, Last updated: 12/03/2021generic formulation (IFOSFAMIDE EG®). J Clin Pharm Ther. 2019;44:372–380 … -
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Press release: Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing
PRAC, Last updated: 12/04/2019suggestive of hepatic dysfunction (e.g. unexplained nausea, vomiting … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 October 2020
Virtual meeting, from 26/10/2020 to 29/10/2020, Last updated: 08/01/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 23-26 November 2020
Virtual meeting, from 23/11/2020 to 26/11/2020, Last updated: 27/11/2020 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2020
European Medicines Agency, Amsterdam, the Netherlands, from 06/07/2020 to 09/07/2020, Last updated: 10/12/2020 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 September-1 October 2020
Virtual meeting, from 28/09/2020 to 01/10/2020, Last updated: 29/09/2020 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018
European Medicines Agency, London, UK, from 11/06/2018 to 14/06/2018, Last updated: 10/08/2018 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 September 2018
PRAC, Last updated: 07/09/2018http://www.efsa.europa.eu) EGA European Generic Medicines … Medicines Association (http://www.egagenerics.com) EMA European Medicines … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 July 2018
PRAC, Last updated: 13/07/2018http://www.efsa.europa.eu) EGA European Generic Medicines … Medicines Association (http://www.egagenerics.com) EMA European Medicines … -
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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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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2018
PRAC, Last updated: 15/06/2018http://www.efsa.europa.eu) EGA European Generic Medicines … Medicines Association (http://www.egagenerics.com) EMA European Medicines … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 May 2018
PRAC, Last updated: 18/05/2018http://www.efsa.europa.eu) EGA European Generic Medicines … Medicines Association (http://www.egagenerics.com) EMA European Medicines … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 April 2018
PRAC, Last updated: 13/04/2018http://www.efsa.europa.eu) EGA European Generic Medicines … Medicines Association (http://www.egagenerics.com) EMA European Medicines … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017
PRAC, Last updated: 01/12/2017measurable health outcomes (e.g. reduction of harm from adverse … consequences in daily healthcare (e.g. switching patterns, conditions … reported to regulatory agencies e.g. in PSURs. The systematic …