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Search results with tag "The smpc"
Generic/hybrid/biosimilar products - European Medicines …
www.ema.europa.euSmPC information • In general, the content of the SmPC should be consistent with the reference medicinal product • Any differences with the reference medicinal product should be
London, 20 November 2008 - European Commission
ec.europa.euPage 3 of 29 SUMMARY OF PRODUCT CHARACTERISTICS: Principles of presenting information - The SmPC should be worded in clear and concise language. - Each section of the SmPC should first deal with those issues that apply to the core population for