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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).
Complete the defective product report template and submit to qdefect@ema.europa.eu: Defective product report form. Note: This form needs to be opened with a PDF reader. EMA advises to save the document first, and then open with a PDF reader, such as Acrobat Reader. For guidance on using the template, see: How to use the defective product report ...
How to use the (suspected) falsified medicinal product report template to report a case of (suspected) falsified medicinal product to European Medicines Agency; You should receive an acknowledgement in four hours during EMA business hours. If you do not, you can phone EMA on: Tel. +31(0)88 781 6000 (EMA switchboard) Tel. +31(0)88 781 7676
Marketing and/or manufacturing authorisation holders are required to use the defective product report template to notify EMA of: quality defects of centrally authorised medicines; restrictions in supply due to a quality defect or good manufacturing practice issue impacting centrally authorised medicines.
Version 1.8. This guidance reflects the current state of knowledge and is subject to future updates to take new information on-board. Therefore, it is important that comments are fed back to the eAF User Group by e-mail EMA IT service desk (https://servicedesk.ema.europa.eu).
Reporting procedures. In general, EMA staff members are expected to report a possible fraudulent behaviour of which they are aware to their immediate superior or to the Executive Director (Article 22a of the Staff Regulations).
Europejska Agencja Leków (EMA) 22 lutego 2013 roku zatwierdziła zmienioną Charakterystykę Produktu Leczczniedgo Emend.
