Community register of orphan medicinal products
| GRANTED |
Product information |
Maribavir
| EU orphan designation number: |
EU/3/07/519
|
| Active ingredient: |
Maribavir |
| Indication: |
Prevention of cytomegalovirus (CMV) disease in patients with impaired cell mediated immunity deemed at risk |
| Sponsor: |
Shire Pharmaceuticals Ireland Limited
5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
|
Public summary of scientific opinion
European Commission procedures |
|
| Close date procedure |
Procedure type |
EMEA number |
Decision |
summary publ |
decision docs |
annex |
| 21/12/2007 |
Orphan designation
|
EMEA/OD/067/07 |
(2007)6799 of 18/12/2007 |
|
|
|
| 21/07/2008 |
Change of name and/or address of sponsor
|
EMEA/OD/067/07 |
|
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| 21/07/2008 |
Change of name and/or address of sponsor
|
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|
| 24/02/2009 |
Transfer of orphan designation
|
EMEA/OD/067/07/T/01 |
(2009)1274 of 20/02/2009 |
|
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| 18/12/2009 |
Change of name and/or address of sponsor
|
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| 17/03/2011 |
Change of name and/or address of sponsor
|
EMEA/OD/067/07 |
|
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| 19/02/2016 |
Change of name and/or address of sponsor
|
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| 18/03/2016 |
Transfer of orphan designation
|
EMA/OD/067/07/T/02 |
(2016)1713 of 15/03/2016 |
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