Nano-enabled medicinal products: time for an international advanced community?

Considerations on paediatric investigation plans for advanced therapy medicinal products

In Europe, advanced therapy medicinal products (ATMPs) are subject to the requirements laid down in the Paediatric Regulation. A company developing an ATMP must therefore obtain agreement from the EMA on a paediatric investigation plan (PIP) or waiver prior to submitting its marketing authorisation application (MAA). Because ATMPs are different from ‘conventional’ medicinal products, defining t...

Ergot derivatives containing medicinal products International Non-proprietary Name: dihydroergotoxine

Ergot derivatives containing medicinal products International Non-proprietary Name: nicergoline

Metoclopramide only containing medicinal products International Non-proprietary Name: metoclopramide

Ergot derivatives containing medicinal products International Non-proprietary Name: dihydroergocristine