Skyclarys

Medicinal product

(Invented) name

Skyclarys

Active substance (s)

Omaveloksolonas

Strength

50 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07XX25, omaveloxolone

Marketing authorisation holder

Biogen Netherlands B.V., Nyderlandai

Date of authorisation

2024-02-09

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, hard	1 vnt.
Omaveloksolonas	50 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
112786	98905	1098905	buteliukas	N90		Receptinis	EU/1/23/1786/001	Netiekiama	-	-	No	-	-
112787	98906	1098906	buteliukas	N270 (3×90)		Receptinis	EU/1/23/1786/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-09	Registruotas