Lenalidomide Zentiva

Medicinal product

(Invented) name

Lenalidomide Zentiva

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)

No

ATC code (s)

L04AX04, Lenalidomide

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2018-05-29

Date of renewal

2022-12-19

Documents

Lenalidomide Zentiva_Sveikatos prieziuros sp. brosiura.pdf

Lenalidomide Zentiva_NR reportavimo forma.pdf

4228 Pakuotės lapelis 2024 01 01.docx

4228 Lenalidomide Zentiva PCS 2024 02 28.docx

Lenalidomide Zentiva_Paciento kortele.pdf

Lenalidomide Zentiva_Vaistines patvirtinimo forma.pdf

Lenalidomide Zentiva_Nestumo raportavimo forma.pdf

Lenalidomide Zentiva_Paciento brosiura.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0270/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	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
99515	85622	1085622	lizdinė plokštelė	N7		Receptinis	LT/1/18/4228/001	Netiekiama	-	-	No	-	-
99516	85623	1085623	lizdinė plokštelė	N21		Receptinis	LT/1/18/4228/002	Netiekiama	2025-01-10	2025-03-31	No	-	-

Stadijos

Data	Stadija
2022-12-19	Perregistruotas
2018-05-29	Registruotas