Lenalidomide Krka [Lenalidomide Krka d.d. Novo mesto]

Medicinal product

(Invented) name

Active substance (s)

Lenalidomidas

Strength

5 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

L04AX04, Lenalidomide

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2021-02-11

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, hard	1 vnt.
Lenalidomidas	5 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
105988	92089	1092089	dalomoji lizdinė plokštelė	N7x1		Receptinis	EU/1/20/1519/003	Netiekiama	-	-	No	-	-
105989	92090	1092090	dalomoji lizdinė plokštelė	N21x1		Receptinis	EU/1/20/1519/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-11	Registruotas