It is a medicinal product intended for a rare disease, i.e. it is intended for an indication with a prevalence not exceeding 5 out of 10,000 persons in the EU, a life-threatening, severely debilitating or a serious and chronic condition.
It is a medicinal product intended for a rare disease, i.e. it is intended for an indication with a prevalence not exceeding 5 out of 10,000 persons in the EU, a life-threatening, severely debilitating or a serious and chronic condition.
