EMEA: QRD recommendations on the expression of strength in the name of centrally authorised human medicinal products.
22.01.2010
Directive 2001/83/EC requires a medicinal product labeled as invented name – strength-pharmaceutical form. The strength in the name of the product is the quantity of the active substance which is relevant for the correct identification and use the product.
Źródło wiadomośći: http://www.ema.europa.eu/htms/human/qrd/docs/70722909en.pdf
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