Date: 2012-04-06
Type of information: Granting of the orphan status in the EU
Product name: adenovirus-associated viral vector serotype 2 containing the human RPE65 gene
Compound: adenovirus-associated viral vector serotype 2 containing the human RPE65 gene
Therapeutic area: Rare diseases - Genetic diseases - Ophtalmological diseases
Action mechanism: gene therapy
Company: Alan Boyd Consultants Ltd (UK)
Disease: Leber’s congenital amaurosis
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: 2012-04-06
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: