“…On 18 September 2017, a marketing authorisation valid through the European Union (EU) was issued for midostaurin in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy and for patients in complete response followed by midostaurin single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are Fms-like tyrosine kinase 3 mutation positive and as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL). …”
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“…The EFSA Panel on Plant Health performed a pest categorisation of Spodoptera eridania (Lepidoptera: Noctuidae) for the European Union (EU). S. eridania (southern armyworm) is a highly polyphagous pest native to the Americas which has spread to Africa being first reported there in 2016. …”
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“…The Panel concluded that: [1] the treatments are of no safety concern, provided that the substances comply with the European Union specifications for food additives; [2] spraying of pork carcasses pre‐chill with lactic acid was efficacious compared to untreated control, but based on the available data, the Panel could not conclude whether lactic acid was more efficacious than water treatment when spraying of pork carcasses pre‐chill or pork meat cuts post‐chill. …”
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“…The product is authorised in the European Union for chickens for fattening at the maximum content of 1,000 mg/kg complete feedingstuffs. …”
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“…The Panel on Plant Health performed a pest categorisation of the fungus Synchytrium endobioticum, the causal agent of potato wart disease, for the European Union (EU). The identity of the pest is well established and reliable methods exist for its detection and identification. …”
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“…The Panel on Plant Health performed a pest categorisation of the South African citrus thrips, Scirtothrips aurantii Faure (Thysanoptera: Thripidae), for the European Union (EU). This is a well‐defined and distinguishable species, recognised as a pest of citrus and mangoes in South Africa, which has been cited on more than 70 different plants, including woody and herbaceous species. …”
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“…Many different Gymnosporangium species are recognised, of which at least 14 species are considered not to be native in the European Union. All the non‐EU Gymnosporangium species are not known to be present in the EU and are regulated in Council Directive 2000/29/EC (Annex IAI) as harmful organisms whose introduction into the EU is banned. …”
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“…The Panel on Plant Health performed a pest categorisation of the citrus thrips, Scirtothrips citri (Moulton) (Thysanoptera: Thripidae), for the European Union (EU). This is a well‐defined and distinguishable species, occurring in North America and Asia. …”
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“…The EFSA Panel on Plant Health performed a pest categorisation of naturally‐spreading psorosis of citrus for the European Union. Naturally‐spreading psorosis is poorly defined, because the status of both the disease and its causal agent(s) is uncertain. …”
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“…The EFSA Panel on Plant Health performed a pest categorisation of non‐EU isolates of Beet curly top virus (BCTV) for the European Union territory. The virus causes severe diseases in beet, tomatoes and pepper crops, occurs predominantly in warm and dry zones and is reported from many countries outside the EU in particular from western USA and Mexico. …”
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“…The ongoing Zika virus (ZIKV) outbreak in Latin America, the Caribbean, and the Pacific Islands has underlined the need for a coordinated research network across the whole region that can respond rapidly to address the current knowledge gaps in Zika and enhance research preparedness beyond Zika. The European Union under its Horizon 2020 Research and Innovation Programme awarded three research consortia to respond to this need. …”
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“…Metal levels in the seafood species studied here were put into context using international regulation for human consumption set by the Food and Agriculture Organization (FAO), Canadian Food Inspection Agency (CFIA), European Union (EU), and World Health Organization (WHO). …”
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“…PURPOSE: The objectives of this analysis were to characterize the population pharmacokinetics (PK) of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin(®)) sourced from the European Union (bevacizumab-EU) in patients with advanced non-squamous non-small cell lung cancer (NSCLC), and to quantify the difference in PK parameters between the two drug products via covariate analysis. …”
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“…The use of advanced cellular models, as an alternative to replace animal testing in the safety evaluation for both consumer products and ingredients, is already mandated by law in the European Union (EU) and other countries. However, there has not yet been a large-scale comparison of the effects of topical-use compounds in different cellular skin models. …”
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“…OBJECTIVES: Smoking prevalence in Greece is considered high within the European Union and the collection of evidence on tobacco use among adolescents is of vital importance in order to develop effective smoking prevention and cessation programmes. …”
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“…OBJECTIVES: To investigate food price drivers for household food security and its health consequences in the UK under scenarios of Deal and No-deal for Britain’s exit from the European Union. To estimate the 5% and 95% quantiles of the projected price distributions. …”
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“…BACKGROUND: The UK has experienced significant immigration from Eastern Europe following European Union (EU) expansion in 2004, which raises the importance of equity and equality for the recent immigrants. …”
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“…Yersinia enterocolitica is generally considered an important food-borne pathogen worldwide, especially in the European Union. A lytic Yersinia phage X1 (Viruses; dsDNA viruses, no RNA stage; Caudovirales; and Myoviridae) was isolated. …”
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“…BACKGROUND: Despite numerous campaigns and interventions to end female genital mutilation (FGM), the practice persists across the world, including the European Union (EU). Previous interventions have focused mainly on awareness raising and legislation aimed at criminalizing the practice. …”
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“…Background: The objective of this study was to demonstrate the pharmacokinetic and pharmacodynamic similarity among SAR341402 insulin aspart biosimilar/follow-on product, United States-sourced insulin aspart (NovoLog(®)), and European Union-sourced insulin aspart (NovoRapid(®)). …”
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