Table 1.

Characteristics of the study population and the medicines prioritized by the Swedish Early Awareness and Alert (EAA) System

Characteristic	Study populationa		EAA System prioritized medicinal products
	n	%	n	%
Medicinal products
New active substanceb	217	86	66	93
Known active substance	36	14	5	7
Total	253	100	71	100
Marketing authorization status
Authorized	210	83	64	90
Refused	14	6	4	6
Withdrawn	29	11	3	4
Orphan
Yes	63	25	14	20
No	190	75	57	80
Year
2010	21	8	9	13
2011	37	15	10	14
2012	34	13	14	20
2013	53	21	13	18
2014	52	21	12	17
2015	56	22	13	18
Therapeutic area based on the ATC classification system
Alimentary tract and metabolism	31	12	6	8
Blood and blood-forming organs	20	8	2	3
Cardiovascular system	15	6	5	7
Dermatologicals	5	2	1	1
Genito-urinary system and sex hormones	8	3	1	1
Systemic hormonal preparations, excluding sex hormones and insulins	3	1	0	0
Anti-infectives for systemic use	27	11	4	6
Antineoplastic and immunomodulating agents	74	29	36	51
Musculoskeletal system	7	3	3	4
Nervous system	21	8	4	6
Anti-parasitic products, insecticides and repellents	1	0	0	0
Respiratory system	10	4	5	7
Sensory organs	6	2	1	1
Various	16	6	2	3
ATC missing	9	4	1	1

ATC Anatomical Therapeutic Chemical, EMA European Medicines Agency

^aMedicinal products authorized or refused by EMA and withdrawals of initial marketing authorization applications

^bA chemical substance not previously authorized as a medicinal product in the European Union; or an isomer, mixture of isomers, a complex or derivative or salt of a chemical substance previously authorized as a medicinal product in the European Union but significantly differing in properties with regard to safety and efficacy from that chemical substance previously authorized