EMEA: QRD Recommendations on the expression of strength in the name of centrally authorised human medicinal products

Directive 2001/83/EC requires a medicinal product to be labelled as “(invented) name + strength + pharmaceutical form”. This is considered to be the full name of the product, therefore wherever in this document reference is made to “name”, it is understood to mean the full name of the product containing the three elements. The active substance is required to be indicated immediately below the full name.