European Union Reference Date(The EU reference date corresponds to the date of the first marketing authorisation of a medicine containing that active substance or that combination of active substances in the EU, or alternatively the earliest of the known dates of the marketing authorisations for a medicine containing that active substance or that combination of active substances. europa.euLEkt)
protocol assistance(лекарственных средств, предназначенных для лечения тяжёлых редких заболеваний, бесплатно направляемая фармпроизводителями в регуляторные органы Dimpassy)
