Table 2.

PIP and no-PIP paediatric medicines characteristics.

	PIP GROUP (p-MPs 136/p-ASs 130)			no-PIP GROUP (p-MPs 160/p-ASs 86)
	art. 7-new products	art. 8-in patent products	art. 30-off patent products	Generics (art. 10.1)	Biosimila (art. 10.4)	Hybrid and well-established use (art. 10.3, art 10a, art 10b, art 10c)
p-MPs	92	38	6	71	31	58
p-ASs (new)*	88	34	6	0	0	47
Biol/ATMPs	53	21	0	0	0	11
p-OMPs	35	6	0	0	0	16
AM**	65	2	0	3	19	11
CA***	23	1	0	0	0	9

^*ASs granting new paediatric indication, dosage, age group;

^**additional monitoring;

^***conditional approval, including also exceptional circumstances and accelerated assessment.