Date: 2012-04-05
Type of information: Granting of the orphan status in the EU
Product name: autologous haematopoietic cells genetically modified with a lentiviral vector containing the human gp91(phox) gene
Compound: autologous haematopoietic cells genetically modified with a lentiviral vector containing the human gp91(phox) gene
Therapeutic area:
Action mechanism:
Company: Généthon (France)
Disease: X-linked chronic granulomatous disease
Latest news:
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE: 2012-02-09
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: