. 2017 Sep 22;7:15–19. doi: 10.1016/j.omtm.2017.08.005

Table 2.

ATMP’s Special Approval Considerations

ATMP	Glybera	MACI	Provenge	Holoclar	Imlygic	Strimvelis	Zalmoxis
Special approval considerations	Orphan designation, additional monitoring,^a and exceptional circumstances	Additional monitoring^a	Additional monitoring^a	Orphan designation, conditional approval and additional monitoring^a	Additional monitoring^a	Orphan designation and additional monitoring^a	Orphan designation, conditional approval, and additional monitoring^a

A medicinal product is usually subject to additional monitoring when there is less information available on it than other medicines, for example, because it is new to the market or there is limited data on its long-term use. It does not mean that the medicine is unsafe.