The Voice of Rare Disease
Patients in Europe
List of the latest marketing authorisations and orphan medicinal products designations
Detailed information on European orphan medicinal products designation applications is available on the EMA website. A full list of designated and authorised orphan medicinal products in Europe available at: ec.europa.eu.
Learn more about the Orphan designation process in Europe
Latest orphan medicines designations
- Orphan medicines designations May 2016
- Orphan medicines designations Apr 2016
- Orphan medicines designations Mar 2016
- Orphan medicines designations Feb 2016
- Orphan medicines designations Jan 2016
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Applications withdrawn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
|
2016
|
252
|
186
|
55
|
1
|
137
|
8
|
8
|
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
|
2637
|
1793
|
662
|
22
|
1733
|
122
|
136
|
Adapted from the Sept 2016 Committee for Orphan Medicinal Products (COMP) meeting report
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