Elenco delle ultime designazioni di farmaco orfano
2019
2018
2017
Overview of Orphan Medicinal Product Designation Procedure since 2000
Year
|
Applications submitted
|
Positive COMP opinions
|
Applications withdrawn
|
Negative COMP opinions
|
Designations granted by the Commission
|
Orphan medicinal products authorised
|
Orphan designations included in authorised therapeutic indication
|
2018
|
203
|
152
|
79
|
3
|
126
|
12
|
15
|
2017
|
260
|
144
|
96
|
2
|
138
|
14
|
15
|
2016
|
330
|
220
|
82
|
2
|
209
|
14
|
14
|
2015
|
258
|
177
|
94
|
1
|
190
|
14
|
21
|
2014
|
329
|
196
|
61
|
2
|
187
|
15
|
16
|
2013
|
201
|
136
|
60
|
1
|
136
|
7
|
8
|
2012
|
197
|
139
|
52
|
1
|
148
|
10
|
12
|
2011
|
166
|
111
|
45
|
2
|
107
|
5
|
5
|
2010
|
174
|
123
|
51
|
2
|
128
|
4
|
4
|
2009
|
164
|
113
|
23
|
0
|
106
|
9
|
9
|
2008
|
119
|
86
|
31
|
1
|
73
|
6
|
7
|
2007
|
125
|
97
|
19
|
1
|
98
|
13
|
13
|
2006
|
104
|
81
|
20
|
2
|
80
|
9
|
11
|
2005
|
118
|
88
|
30
|
0
|
88
|
4
|
4
|
2004
|
108
|
75
|
22
|
4
|
73
|
6
|
6
|
2003
|
87
|
54
|
41
|
1
|
55
|
5
|
5
|
2002
|
80
|
43
|
30
|
2
|
49
|
4
|
4
|
2001
|
83
|
62
|
27
|
1
|
64
|
3
|
3
|
2000
|
72
|
26
|
6
|
0
|
14
|
0
|
0
|
Total
|
3211
|
2134
|
881
|
28
|
2121
|
164
|
185
|
Adapted from the July 2018 Committee for Orphan Medicinal Products (COMP) meeting report