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Community Register of medicinal products
Community register of orphan medicinal products | GRANTED |
Product information |
Nitisinone
| EU orphan designation number: | EU/3/00/012
|
| Active ingredient: | Nitisinone |
| Indication: | Treatment of tyrosinaemia type I |
| Sponsor: | Swedish Orphan International AB
SE-112 76, Stockholm, Sverige |
| EU Centralised marketing authorisation: | A centralised EU marketing authorisation has been obtained under the name Orfadin on 21/02/2005 with the number EU/1/04/303 |
Public summary of scientific opinion
EPAR
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 30/01/2001 | Centralised Orphan - Designation | EMEA/OD/011/00 | (2000)4047 of 29/12/2000 |