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Press release: PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel
PRAC, Last updated: 09/06/2017EMA/365357/2017 Generic Docetaxel Accord: EPAR Docetaxel Kabi: EPAR … -
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Press release: EMA concludes safety review of Uptravi
PRAC, Last updated: 07/04/2017cine can continue to be used according to the prescribing informatio … Medicine can continue to be used according to the prescribing information … new and existing patients, according to the current prescribing … -
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News: Committee for paediatric medicinal products - towards more and better information on the use of medicines for children
PDCO, Last updated: 18/02/2013medicine for children in accordance with the requirements of … formulated and investigated according to their specific needs … EMA/PDCO/388684/2012 Page 2/6 According to Art. 25(2) of the Universal … -
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News: PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
PRAC, Last updated: 11/02/2022ensure HES solutions are used according to the Documents providing … or more Member States in accordance with the mutual recognition … -
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Press release: PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines
PRAC, Last updated: 13/02/2015information should be updated accordingly. The PRAC recommendation will … information should be updated accordingly. The PRAC recommendation … -
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Press release: PRAC recommends new measures to avoid dosing errors with methotrexate
PRAC, Last updated: 12/07/2019medicines and to counsel patients accordingly. Tablets to be available in … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 April 2017
PRAC, Last updated: 07/04/2017new and existing patients according to the current prescribing … -
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Press release: EMA reviewing cancer medicine docetaxel
PRAC, Last updated: 10/03/2017to prescribe this medicine according to recommendations in the … prescribe this medicine according to recommendations in the … -
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Press release: EMA restricts use of multiple sclerosis medicine Zinbryta
PRAC, Last updated: 07/07/2017information will be updated accordingly. Further information will … information will be updated accordingly. • Further information … -
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Press release: EMA recommends new safety measures for Zydelig
PRAC, Last updated: 18/03/2016information will be updated accordingly. Further information on the … information will be updated accordingly. EMA recommends new … -
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News: Paper calls for continued support for development of advanced therapies
CAT, Last updated: 13/03/2012advanced-therapy medicines, according to a paper published in the … transitional period, by which, according to the provisions of Article … workload and resources accordingly - Strengthen dialogue with … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2020
PRAC, Last updated: 13/03/2020assessment. Capecitabine Accord: EPAR Capecitabine Medac … -
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News: European Medicines Agency begins to publish recommendations based on safety signals
PRAC, Last updated: 04/10/2013are expected to take action according to the recommendations. The … are expected to take action according to the PRAC recommendations … Variations for CAPs are handled according to established EMA procedures … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2013
PRAC, Last updated: 12/07/2013in their territories. In accordance with EU legislation, this … -
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Press release: European Medicines Agency holds first meeting of the Pharmacovigilance Risk Assessment Committee (PRAC)
PRAC, Last updated: 19/07/2012being held in Brussels, in accordance with the Agency's planning … being held in Brussels, in accordance with the Agency’s planning … -
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News: General Court upholds European Medicines Agency decision to refuse paediatric waiver for perflubutane
PDCO, Last updated: 15/12/2011perflubutane EMEA-000194-PIP01-08 in accordance with Regulation (EC) No 1901/2006 … EMEA-000194-PIP01-08 in accordance with Regulation (EC) No 1901/2006 … EMEA-000194-PIP01-08 in accordance with Regulation (EC) No 1901/2006 … -
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Press release: New Paediatric Committee holds its first meeting
PDCO, Last updated: 06/07/2007data have been generated in accordance with an agreed paediatric … data have been generated in accordance with an agreed paediatric … -
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Press release: PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C
PRAC, Last updated: 02/12/2016be monitored and managed according to current clinical guidelines … be monitored and managed according to current clinical guidelines … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2016
PRAC, Last updated: 02/12/2016be monitored and managed according to current clinical guidelines … -
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Press release: PRAC recommends using acipimox only as additional or alternative treatment to lower high triglyceride levels
PRAC, Last updated: 08/11/2013medicines should be amended accordingly across the EU. The Committee … medicines should be amended accordingly across the EU. The Committee … -
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Press release: PRAC confirms that hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients
PRAC, Last updated: 11/10/2013in their territories. In accordance with EU legislation, this … in their territories. In accordance with EU legislation, this … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021
PRAC, Last updated: 15/01/2021marketing authorisation holder, according to an agreed communication … adopted or considered public according to the principles stated … -
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News: EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
CHMP, PDCO, PRAC, Last updated: 04/10/2021studied for use in children, in accordance with the accelerated timelines … -
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News: EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19
CHMP, PDCO, PRAC, Last updated: 18/11/2021studied for use in children, in accordance with the accelerated timelines … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021
PRAC, Last updated: 03/12/2021requirements'. product information accordingly. Myocarditis and pericarditis … adopted or considered public according to the principles stated …