Lupkynis

Medicinal product

(Invented) name

Lupkynis

Active substance (s)

Voklosporinas

Strength

7,9 mg

Pharmaceutical form

minkštosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AD03, Voclosporin

Marketing authorisation holder

Otsuka Pharmaceutical Netherlands B.V., Nyderlandai

Date of authorisation

2022-09-15

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, soft	1 vnt.
Voklosporinas	7,9 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
109438	95544	1095544	lizdinė plokštelė	N180		Receptinis	EU/1/22/1678/001	Netiekiama	-	-	No	-	-
110327	96438	1096438	lizdinė plokštelė	N576		Receptinis	EU/1/22/1678/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-15	Registruotas