Date: 2017-06-15
Type of information: Positive opinion for the granting of the orphan status in the EU
Product name: sildenafil
Compound: sildenafil
Therapeutic area: Rare diseases
Action mechanism: phosphodiesterase 5 inhibitor
Company: Avivia Beheer (The Netnerlands)
Disease: congenital diaphragmatic hernia
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:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: