Opzelura

Medicinal product

(Invented) name

Opzelura

Active substance (s)

Ruksolitinibas

Strength

15 mg/g

Pharmaceutical form

kremas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D11AH09, ruxolitinib

Marketing authorisation holder

Incyte Biosciences Distribution B.V., Nyderlandai

Date of authorisation

2023-04-19

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

Cream	1 g
Ruksolitinibas	15 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
110891	97002	1097002	tūbelė	100 g N1 (al)		Receptinis	EU/1/23/1726/001	Netiekiama	-	-	No	-	-
111191	97302	1097302	tūbelė	100 g N1 (laminuota)		Receptinis	EU/1/23/1726/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-19	Registruotas