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News: EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17
CHMP, Last updated: 08/06/2021study was carried out in accordance with the paediatric investigation … -
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Press release: EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans
CHMP, Last updated: 21/07/2017EU market will be updated accordingly. Healthcare professionals … EU market will be updated accordingly. • Healthcare professionals … -
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Press release: Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B
CHMP, Last updated: 16/12/2016be monitored and managed according to current clinical guidelines … be 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 Committee for Medicinal Products for Human Use (CHMP) 17-20 October 2011
CHMP, Last updated: 21/10/2011application/pdf Repaglinide Accord repaglinide Accord Healthcare Ltd … -
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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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Press release: European Medicines Agency recommendations on extension of shelf life for Tamiflu
CHMP, Last updated: 08/05/2009available to the public, in accordance with national preparedness … available to the public, in accordance with national preparedness … -
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Press release: European Medicines Agency recommends new contraindication for Fareston (toremifene)
CHMP, Last updated: 22/01/2009should prescribe Fareston according to the updated product information … should prescribe Fareston according to the updated product information … -
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Press release: EMEA recommends authorisation of first pre-pandemic influenza vaccine
CHMP, Last updated: 21/02/2008declared influenza pandemic, in accordance with official guidance. An … declared influenza pandemic, in accordance with official guidance … -
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Press release: European Medicines Agency statement on the safety of Gardasil
CHMP, Last updated: 24/01/2008of Gardasil should be in accordance with official recommendations.” … of Gardasil should be in accordance with official recommendations.” … -
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Press release: EMA recommendations on DPD testing prior to treatment with fluorouracil, capecitabine, tegafur and flucytosine
CHMP, Last updated: 30/04/2020EMA/229267/2020 Generic Capecitabine Accord: EPAR Capecitabine Medac … -
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Press release: European Medicines Agency recommends suspension of Hexavac
CHMP, Last updated: 20/09/2005Vaccination should be continued according to national recommendations … Vaccination should be continued according to national recommendations … Vaccination should be continued according to national recommendations … -
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Press release: European Medicines Agency consulting on a draft guideline on pharmacovigilance for medicines used in children
CHMP, Last updated: 12/08/2005of medicines in children. According to the European Commission … medicines in children. According to the European Commission … -
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Press release: Updated measures for pregnancy prevention during retinoid use
CHMP, Last updated: 23/03/2018the skin, must be used in accordance with the conditions of a … the skin, must be used in accordance with the conditions of a … isotretinoin must be used in accordance with the conditions of a … -
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Press release: European Medicines Agency recommends approval of Gazyvaro for chronic lymphocytic leukaemia
CHMP, Last updated: 23/05/2014profile of Gazyvaro was in accordance with what would be expected … profile of Gazyvaro was in accordance with what would be expected … -
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News: World Diabetes Day – more treatment options to meet needs of growing patient numbers
CHMP, Last updated: 14/11/2013available treatment options. According to the World Health Organization … -
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Press release: European Medicines Agency recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)
CHMP, Last updated: 21/11/2014Corlentor/Procoralan will be updated accordingly. … -
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Press release: European Medicines Agency completes review of polymyxin-based medicines
CHMP, Last updated: 24/10/2014given. Doses should be reduced according to creatinine clearance in … Doses should be reduced according to creatinine clearance in … IU twice daily, adjusted according to the severity of the condition … -
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Press release: Combined use of medicines affecting the renin-angiotensin system (RAS) to be restricted – CHMP endorses PRAC recommendation
CHMP, Last updated: 23/05/2014RAS-acting agents will be amended accordingly. References: 1. Yusuf S, Teo … RAS-acting agents will be amended accordingly. References. 1. Yusuf … -
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Press release: European Medicines Agency confirms positive benefit-risk balance of MabThera
CHMP, Last updated: 25/05/2012Regulation (EC) No 726/2004/EC. According to the World Health Organization … EC) No 726/2004/EC. 6. According to the World Health Organization … -
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Press release: European Medicines Agency agrees to precautionary recall of Advagraf 0.5 mg capsule batches
CHMP, Last updated: 20/10/2011medicines have not worked. According to the information provided … medicines have not worked. According to the information provided … -
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Press release: European Medicines Agency gives first positive opinion for paediatric-use marketing authorisation
CHMP, Last updated: 24/06/2011use-marketing authorisation according to Article 30 of Regulation … use-marketing authorisation according to Article 30 of Regulation … -
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Press release: European Medicines Agency updates treatment recommendations because of continued Fabrazyme shortage
CHMP, Last updated: 06/07/2010before the end of this year, according to Genzyme. Fabrazyme is … before the end of this year, according to Genzyme. Fabrazyme is … -
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Press release: European Medicines Agency recommends lifting of supply and treatment restrictions for Neupro
CHMP, Last updated: 29/05/2009Neupro to all patients in accordance with the approved product … Neupro to all patients in accordance with the approved product … -
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News: Public Statement: Epoetins and the risk of tumour growth progression and thromboembolic events in cancer patients and cardiovascular risks in patients with chronic kidney disease
CHMP, Last updated: 23/10/2007use epoetins strictly in accordance with their approved Summaries … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2010
CHMP, Last updated: 23/07/2010special circumstances, in accordance with official recommendations … special circumstances, in accordance with official recommendations … basis of data generated in accordance with an agreed paediatric …