miércoles, 27 de julio de 2016

Latest marketing authorisations and orphan drug designations

Latest marketing authorisations and orphan drug designations

Eurordis, Rare Diseases Europe

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 theEMA website. A full list of designated and authorised orphan medicinal products in Europe available at:ec.europa.eu.

Orphan drug regulatory processLearn more about the Orphan designation process in Europe






Latest orphan medicines designations

 

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Applications withdrawn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
173
128
35
0
112
7
7
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
2558
1735
642
21
1708
121
135
Adapted from the July 2016 Committee for Orphan Medicinal Products (COMP) meeting report
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