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Products

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:

  • On May 12, 2017, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for sildenafil for treatment of congenital diaphragmatic hernia.

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:

Is general: Yes