Products

Date: 2017-06-15

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

Product name: sirolimus

Compound: sirolimus

Therapeutic area: Rare diseases - Genetic diseases - Dermatological diseases

Action mechanism: immunosuppressive agent

Company: Raremoon Consulting (UK - USA - MD)

Disease: pachyonychia congenita

Latest news:

• On June 15, 2017 , the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for sirolimus for treatment of pachyonychia congenita.

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