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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).
- EMEND, INN-aprepitant - ema.europa.eu
EMEND, INN-aprepitant. Procedural steps taken and scientific...
- EMEND, INN-aprepitant - ema.europa.eu
EMEND, INN-aprepitant. Procedural steps taken and scientific information after the authorisation. Notifications are issued for type I variations and Article 61(3) notifications (unless part of a group including a type II variation or extension application or a worksharing application). Opinions are issued for all other procedures.
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.
This decentralised procedure concerns a generic application claiming essential similarity with the innovator product Emend 80 mg and 125 mg hard capsules(EU/1/03/262) which has been registered in the EEA by Merck Sharp & Dohme Ltd, UK since 11 November 2003 (original product).
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).
On 16 March 2017, the MAH submitted a completed paediatric study for Emend, in accordance with Article 46 of Regulation (EC) No1901/2006, as amended. These data are also submitted as part of the follow up measure(s). A short critical expert overview has also been provided.
tests during treatment with EMEND, - antibiotics to treat infections – such as rifampicin, clarithromycin, telithromycin, - phenytoin - for fits (seizures),
