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Pharmaceuticals - Community Register
Community register of orphan medicinal products | GRANTED |
Product information |
Trabectedin
| EU orphan designation number: | EU/3/03/171
|
| Active ingredient: | Trabectedin |
| Indication: | Treatment of ovarian cancer |
| Sponsor: | Pharma Mar S.A.
Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España |
| EU Centralised marketing authorisation: | A centralised EU marketing authorisation has been obtained under the name Yondelis on 17/09/2007 with the number EU/1/07/417 |
Public summary of scientific opinion
EPAR
European Commission procedures |
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 22/10/2003 | Orphan designation | EMEA/OD/044/03 | (2003)3935 of 17/10/2003 |


