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Community Register of medicinal products
Community register of orphan medicinal products | GRANTED |
Product information |
Dasatinib
| EU orphan designation number: | EU/3/05/339
|
| Active ingredient: | Dasatinib |
| Indication: | Treatment of chronic myeloid leukaemia |
| Sponsor: | Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
| EU Centralised marketing authorisation: | A centralised EU marketing authorisation has been obtained under the name Sprycel on 20/11/2006 with the number EU/1/06/363 |
Public summary of scientific opinion
EPAR
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 03/01/2006 | Centralised Orphan - Designation | EMEA/OD/075/05 | (2005)5975 of 23/12/2005 |