Products

Date: 2017-06-15

Type of information: Positive opinion for the granting of the orphan status in the EU

Product name: retinol

Compound: retinol

Therapeutic area: Rare diseases - Ophtalmological diseases

Action mechanism: vitamine

Company: Orphanix (Austria)

Disease: prevention of retinopathy of prematurity

Latest news:

• On June 15, 2017, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for retinol for prevention of retinopathy of prematurity.

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