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Emend is an antiemetic, a medicine that prevents nausea (feeling sick) and vomiting. Emend is used in patients aged from 6 months to prevent nausea and vomiting caused by chemotherapy (medicines used to treat cancer).
- ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - European Medicines Agency
EMEND is given for 3 days as part of a regimen that includes...
- ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - European Medicines Agency
A series of questions and answers relating to the guideline on ICH guideline Q11 on the development and manufacture of drug substances became effective in February 2018 (EMA/CHMP/ICH/809509/2016).
EMEND należy przyjmować przez 3 dni w skojarzeniu z kortykosteroidem i antagonistą receptora 5-HT3. Zalecana dawka wynosi 125 mg, raz na dobę, podana doustnie na godzinę przed rozpoczęciem chemioterapii w 1. dniu oraz dawka 80 mg, raz na dobę, podana doustnie rano w 2. i 3. dniu.
We have summarized GMP questions and answers from Regulators around the world. In addition to EMA, FDA, Health Canada, MHRA (UK), and ICH we have also used Q&As from the ECA Foundation.
EMEND is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. The recommended dose is 125 mg orally once daily one hour before start of chemotherapy on Day 1 and 80 mg orally once daily on Days 2 and 3 in the morning.
Zapobieganie nudnościom i wymiotom związanym z przeciwnowotworową chemioterapią o wysokim i umiarkowanym ryzyku wymiotów u dorosłych i młodzieży w wieku od 12 lat. EMEND 125 mg/80 mg stosuje się w leczeniu skojarzonym (patrz punkt 4.2).
31 sty 2024 · The European Medicines Agency (EMA) publishes answers to frequently asked questions on good manufacturing practice (CGMP) and good distribution practice (GDP) on its website at irregular intervals, as discussed and agreed by the GMP/GDP inspectors' working group.
