Date: 2011-12-19
Type of information: Granting of a patent
Product name: Carbaglu®
Compound: carglumic acid
Therapeutic area:
Action mechanism:
Company: Orphan Europe - Recordati group (Italy)
Disease: treatment of hyperammoniaemia due to isovaleric acidaemia, methylmalonic acidaemia and propionic acidaemia
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: 2010-02-01
UE authorization: 2011-06-01
Favourable opinion UE: 2011-04-14
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
