207 results
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Press release: CMDh endorses suspension of methadone oral solutions containing high molecular weight povidone
CMDh, Last updated: 24/07/2014of lower molecular weight (e.g. K25 and K30), the available … of lower molecular weight (e.g. K25 and K30), the available … molecular weight povidone (e.g. K25 and K30) as this type … -
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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
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: Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis
PRAC, Last updated: 09/07/2021and/or consult specialists (e.g. cardiologists) to diagnose … and/or consult specialists (e.g. cardiologists) to diagnose … -
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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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Press release: Updated advice on use of high-dose ibuprofen
CMDh, Last updated: 22/05/2015cardiovascular conditions (e.g. uncontrolled hypertension … for cardiovascular events (e.g. hypertension, hyperlipidaemia … cardiovascular conditions (e.g. uncontrolled hypertension … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 March 2021
PRAC, Last updated: 12/03/2021generic formulation (IFOSFAMIDE EG®). J Clin Pharm Ther. 2019;44:372–380 … -
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News: COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
PRAC, Last updated: 20/04/2021and/or consult specialists (e.g., haematologists, specialists … and/or consult specialists (e.g., haematologists, specialists … -
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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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Press release: Modified-release paracetamol-containing products to be suspended from EU market
CMDh, Last updated: 15/12/2017taken at suitable intervals (e.g. 4, 6, and 8 hours after … -
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Press release: New safety advice for diclofenac – CMDh endorses PRAC recommendation
CMDh, Last updated: 28/06/2013for cardiovascular events (e.g. hypertension, hyperlipidaemia … for cardiovascular events (e.g. hypertension, hyperlipidaemia … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
PRAC, Last updated: 06/08/2021unexpected vaginal bleeding (e.g. in postmenopausal women … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 July 2021
PRAC, Last updated: 09/07/2021and/or consult specialists (e.g. cardiologists) to diagnose … -
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News: Hydroxyethyl-starch solutions for infusion recommended for suspension from the market (updated)
CMDh, Last updated: 26/07/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 October 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 25/10/2021 to 28/10/2021, Last updated: 02/08/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 July 2021
European Medicines Agency, Amsterdam, the Netherlands, from 05/07/2021 to 08/07/2021, Last updated: 10/05/2022 -
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News: COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
CHMP, PRAC, Last updated: 28/01/2022with mild renal impairment (eGFR ≥ 60 to < 90 mL/min). In … moderate renal impairment (eGFR ≥ 30 to < 60 mL/min), the … severe renal impairment [eGFR < 30 mL/min, including patients …